SarcomaPhase 2NCT00267046
Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma
A Phase 2 study testing Palifermin, Adriamycin (Doxorubicin) and Ifosfamide in people with Sarcoma and Oral Mucositis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary: 1. To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients with sarcoma receiving multicycle chemotherapy. 2. To evaluate the pharmacokinetics (PK) of palifermin when given pre chemotherapy. 3. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Sarcoma, Oral Mucositis
- What is being tested?
- Palifermin, Adriamycin (Doxorubicin) and Ifosfamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with high dose doxorubicin (90 mg/m2) with ifosfamide (AI) or cisplatinum (AP) is indicated.
- Patients (male and female) with childbearing potential (defined as not post-menopausal for 12 months, negative blood pregnancy test, or no previous surgical sterilization) must use adequate birth control.
- Adequate hematologic (Absolute neutrophil count (ANC)>/= 1500/mm^3, >/= Hgb 10gm/dL, platelet count >/= 150,000/mm^3), renal (serum creatinine </= 1.5mg/dL), hepatic (serum bilirubin count </= 1.5 * normal and SGPT < 3 * normal) functions.
- Karnofsky Performance Status >/= 80.
- Signed informed consent form.
Who cannot join
- Pregnant or lactating women.
- Patients with comorbid condition which renders patients at high risk of treatment complication.
- Patients with metastatic disease to CNS.
- Patient has uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia, acute myocardial infarction within 3 months or has uncontrolled hypertension.
- Patient has an active seizure disorder. Patients with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of antiseizure medication for the previous 5 years.
- Prior surgery or radiotherapy (RT) within 2 weeks of study entry.
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- Prior treatment with palifermin, or other keratinocyte growth factors (eg, KGF-2).
- Thirty days or less since receiving an investigational product or device in another clinical trial. Current enrollment in another clinical trial is not permitted unless the sole purpose of the trial is to obtain post-treatment data on the subject (eg, long-term follow-up or survival data).
- Known sensitivity to any of the products to be administered during this study, including Escherichia coli-derived products.
- Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up.
- Patients with a history of pancreatitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Study to Evaluate the Pharmacokinetics, Safety, and Obtain a Preliminary Efficacy Assessment of Palifermin in Patients With Sarcoma Receiving Multicycle Chemotherapy With Doxorubicin and Ifosfamide
Primary:
- To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients with sarcoma receiving multicycle chemotherapy.
- To evaluate the pharmacokinetics (PK) of palifermin when given pre chemotherapy.
- To evaluate the safety profile of palifermin when combined with multicycle chemotherapy.
Exploratory:
- To evaluate the biologic effect of palifermin on oral mucosa.
- To investigate potential biomarker development by biochemical analysis in blood cells, serum, and plasma.
- To investigate the effects of genetic variation in mucositis genes, drug metabolism genes, and drug target genes on patient response to the treatment regimen.
Read the detailed description
Palifermin is similar to a protein keratinocyte growth factor (KGF) that is naturally made in your body in small amounts. The function of palifermin is to stimulate the growth of specific cells that form the tissue lining of your mouth and digestive tract. Damage to these cells results in the breakdown of the normal protective barrier that these cells usually provide, potentially resulting in infection.
If you are eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to receive either palifermin or placebo by vein 3 days before each cycle of chemotherapy. This will be done for 18 weeks (a total of 12 injections). A placebo is a substance that looks like the study drug, but which has no active ingredients. The infusion time will last 15-30 seconds. At the beginning of the study, for every 3 patients who are enrolled on this study, 2 of the 3 will receive palifermin. Neither you nor the study doctor will know which study drug you are assigned to receive.
Within 1 or 2 days before you receive your first dose of palifermin and between 48 to 72 hours after you receive your first dose of palifermin, additional non-invasive optical imaging procedures may be performed. The purpose of these imaging procedures is to evaluate the effects of palifermin on mucosa (mucosal thickness). The types of optical imaging that may be done include optical coherence tomography (OCT), fluorescence and reflectance spectroscopy, or confocal microscopy. The oral cavity will be inspected and photographed. A probe about the size of a pen will be placed on one or two sites of oral buccal mucosa. A beam of light will then be directed to the oral tissue and optical signals will be collected from each site. This will take about 1 minute for each site. Before using the probe for each new participant, it will be disinfected per standard practice.
You will receive adriamycin with ifosfamide or cisplatin chemotherapy. Adriamycin will be given as a continuous infusion through your central venous catheter (CVC) for 3 days. Ifosfamide will be given intravenously (intravenously (IV)--through a needle in your vein) through your CVC over 3 hours, every day for 4 days. Mesna will be given as a 24-hour IV infusion through your CVC every day for 4 days through the same catheter. Mesna is used to protect against bladder-related side effects. For patients with certain types of sarcoma, vincristine will be given through the catheter by rapid infusion on Day 1 only. In patients with bone sarcoma, cisplatin will be given on the first day as IV or intra-arterial infusion over around 4 hours instead of ifosfamide.
You will need to come in to M. D. Anderson every 3 weeks for about 4 to 5 months during the treatment period, unless your doctor decides you need to come in more frequently. At these visits, you will have your vital signs measured and routine blood tests (about 3 teaspoons each) will be performed. In addition, you may have your oral cavity examined and photographed before and after receiving the study drug. Every effort will be made to take photographs in which you cannot be identified.
Additional blood samples (about 3 teaspoons) will be taken before each cycle and as frequently as needed to measure your blood count and other tests to monitor the drug side effects and treatment effects. By the end of the study, you will have given about 10 tablespoons of blood. This amount includes the optional blood draws should you choose to allow it to be drawn.
You will be responsible for notifying study staff (at your doctors visits or over the phone with the study staff) of any side effects you experience or medications (over the counter or prescription) that you take during the treatment period. You will also be required to notify any other doctors (separate from the study doctors) you see that you are participating in this research study.
If your anemia becomes severe while you are on study, then a transfusion may be recommended. If mucositis develops, the prohibited medicines can be allowed for treatment of the condition. If you experience an intolerable side effect while on study, you may be taken off study. If you leave the study early for any reason, your doctor will continue to follow your progress for 4 weeks and will access your medical records for a minimum of 1 year after the last dose of study drug (either palifermin or placebo) was given.
At your end of study visit, you will be evaluated for your disease status with imaging studies [computed tomography (CT) scans or magnetic resonance images (MRI)] and your weight and vitals signs will be measured. You will report any medications you have taken since your last visit and any side effects or blood transfusion that you have had. You will also have a final blood draw (about 3 teaspoons) for routine tests.
The total length of your involvement in this study is expected to be about 18 weeks (4 to 5 months).
- Conditions
- Sarcoma, Oral Mucositis
- Being tested
- Palifermin, Placebo, Adriamycin (Doxorubicin), Ifosfamide, Vincristine
- Keywords
- Sarcoma, Soft Tissue Sarcoma, Oral Mucositis, Doxorubicin, Adriamycin, Ifosfamide, Palifermin, Vincristine, Cisplatin, Placebo
- Medical subject headings
- Sarcoma, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaliferminDrug
180 mcg/kg 3 days prior to chemotherapy
PlaceboDrug
Single dose 3 days prior to chemotherapy
Adriamycin (Doxorubicin)Drug
Also called Adriamycin
30 mg/m^2 IV continuous infusion for 72 hours; days 0, 1, 2 (infusion completing on day 3) (total dose = 90 mg/m^2).
IfosfamideDrug
2.5 g/m^2 IV bolus over 3 hours, days 0,1, 2, 3 (total dose = 10 g/m^2); for patients receiving the AI Regimen.
VincristineDrug
2 mg IV on day 0, for patients with small cell histology receiving the AI Regimen.
CisplatinDrug
Also called CDDP, Platinol
120 mg/m^2 on day 0, for patients receiving the AP Regimen.
| Study group | Role | What they receive |
|---|---|---|
| Palifermin | Experimental | Palifermin + Chemotherapy (Adriamycin (Doxorubicin)+ Ifosfamide (AI) or Adriamycin (Doxorubicin) + Cisplatin (AP) Regimen); Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.
AP=Doxorubicin (Adriamycin) + Cisplatin:
Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0. Receives: Drug: Palifermin; Drug: Adriamycin (Doxorubicin); Drug: Ifosfamide; Drug: Vincristine; Drug: Cisplatin |
| Placebo | Placebo comparator | Placebo + Chemotherapy (AI or AP Regimen);
AI = Doxorubicin (Adriamycin) + Ifosfamide:
A single dose placebo prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.
AP=Doxorubicin (Adriamycin) + Cisplatin:
A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0. Receives: Drug: Placebo; Drug: Adriamycin (Doxorubicin); Drug: Ifosfamide; Drug: Vincristine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence Rate of Oral Mucositis
Cumulative incidence of World Health Organization (WHO) grade 2 or > mucositis (moderate to severe) in participants completing up to 6 blinded cycles. Rate defined as participants who had Grade 2 or > divided by total number of participants who completed up to 6 blinded cycles.
WHO Criteria of Grade 1: possible buccal mucosal scalloping with/without erythema; No ulcers; swallows solid diet. Grade 2: ulcers with or without erythema; swallow solid diet. Grade 3: ulcers with/without (extensive) erythema; swallow liquid, not solid diet. Grade 4: mucositis to extent alimentation not possible.
Measured: Within 6 blinded cycles (3-week cycles), up to 18 weeks.
Median Maximum Score for Patient Reported Outcomes in 2 Blinded Cycles
Median maximum score (0 to 10, with 10 being the worst) for participant-reported outcomes in the first 2 blinded cycles for Mouth Pain, Overall Mouth and Throat Soreness, and Rectal Soreness while median maximum score for Swallowing, Drinking and Eating Difficulty (0 to 4, with 4 being the difficult).
Measured: Within the first 2 blinded cycles (3-week cycles), up to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saroj Vadhan-Raj, M.D., Principal investigator, University of Texas MDAnderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267046
- Sponsor's protocol ID
- 2004-0511
- Status last verified
- Apr 2012
- First submitted
- 19 Dec 2005
- Last updated
- 16 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vadhan-Raj S, Trent J, Patel S, Zhou X, Johnson MM, Araujo D, Ludwig JA, O'Roark S, Gillenwater AM, Bueso-Ramos C, El-Naggar AK, Benjamin RS. Single-dose palifermin prevents severe oral mucositis during multicycle chemotherapy in patients with cancer: a randomized trial. Ann Intern Med. 2010 Sep 21;153(6):358-67. doi: 10.7326/0003-4819-153-6-201009210-00003.
PubMed 20855800
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Pharmacokinetics, Safety, and Obtain a Preliminary Efficacy Assessment of Palifermin in Patients With Sarcoma Receiving Multicycle Chemotherapy With Doxorubicin and Ifosfamide
- ClinicalTrials.gov ID
- NCT00267046
- Acronym / sponsor ID
- 2004-0511
- Conditions
- Sarcoma, Oral Mucositis
- Keywords
- Sarcoma, Soft Tissue Sarcoma, Oral Mucositis, Doxorubicin, Adriamycin, Ifosfamide, Palifermin, Vincristine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 Dec 2005 (estimated)
- Results
- Posted 16 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary:
- To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients with sarcoma receiving multicycle chemotherapy.
- To evaluate the pharmacokinetics (PK) of palifermin when given pre chemotherapy.
- To evaluate the safety profile of palifermin when combined with multicycle chemotherapy.
Exploratory:
- To evaluate the biologic effect of palifermin on oral mucosa.
- To investigate potential biomarker development by biochemical analysis in blood cells, serum, and plasma.
- To investigate the effects of genetic variation in mucositis genes, drug metabolism genes, and drug target genes on patient response to the treatment regimen.
Detailed description
Palifermin is similar to a protein keratinocyte growth factor (KGF) that is naturally made in your body in small amounts. The function of palifermin is to stimulate the growth of specific cells that form the tissue lining of your mouth and digestive tract. Damage to these cells results in the breakdown of the normal protective barrier that these cells usually provide, potentially resulting in infection.
If you are eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to receive either palifermin or placebo by vein 3 days before each cycle of chemotherapy. This will be done for 18 weeks (a total of 12 injections). A placebo is a substance that looks like the study drug, but which has no active ingredients. The infusion time will last 15-30 seconds. At the beginning of the study, for every 3 patients who are enrolled on this study, 2 of the 3 will receive palifermin. Neither you nor the study doctor will know which study drug you are assigned to receive.
Within 1 or 2 days before you receive your first dose of palifermin and between 48 to 72 hours after you receive your first dose of palifermin, additional non-invasive optical imaging procedures may be performed. The purpose of these imaging procedures is to evaluate the effects of palifermin on mucosa (mucosal thickness). The types of optical imaging that may be done include optical coherence tomography (OCT), fluorescence and reflectance spectroscopy, or confocal microscopy. The oral cavity will be inspected and photographed. A probe about the size of a pen will be placed on one or two sites of oral buccal mucosa. A beam of light will then be directed to the oral tissue and optical signals will be collected from each site. This will take about 1 minute for each site. Before using the probe for each new participant, it will be disinfected per standard practice.
You will receive adriamycin with ifosfamide or cisplatin chemotherapy. Adriamycin will be given as a continuous infusion through your central venous catheter (CVC) for 3 days. Ifosfamide will be given intravenously (intravenously (IV)--through a needle in your vein) through your CVC over 3 hours, every day for 4 days. Mesna will be given as a 24-hour IV infusion through your CVC every day for 4 days through the same catheter. Mesna is used to protect against bladder-related side effects. For patients with certain types of sarcoma, vincristine will be given through the catheter by rapid infusion on Day 1 only. In patients with bone sarcoma, cisplatin will be given on the first day as IV or intra-arterial infusion over around 4 hours instead of ifosfamide.
You will need to come in to M. D. Anderson every 3 weeks for about 4 to 5 months during the treatment period, unless your doctor decides you need to come in more frequently. At these visits, you will have your vital signs measured and routine blood tests (about 3 teaspoons each) will be performed. In addition, you may have your oral cavity examined and photographed before and after receiving the study drug. Every effort will be made to take photographs in which you cannot be identified.
Additional blood samples (about 3 teaspoons) will be taken before each cycle and as frequently as needed to measure your blood count and other tests to monitor the drug side effects and treatment effects. By the end of the study, you will have given about 10 tablespoons of blood. This amount includes the optional blood draws should you choose to allow it to be drawn.
You will be responsible for notifying study staff (at your doctors visits or over the phone with the study staff) of any side effects you experience or medications (over the counter or prescription) that you take during the treatment period. You will also be required to notify any other doctors (separate from the study doctors) you see that you are participating in this research study.
If your anemia becomes severe while you are on study, then a transfusion may be recommended. If mucositis develops, the prohibited medicines can be allowed for treatment of the condition. If you experience an intolerable side effect while on study, you may be taken off study. If you leave the study early for any reason, your doctor will continue to follow your progress for 4 weeks and will access your medical records for a minimum of 1 year after the last dose of study drug (either palifermin or placebo) was given.
At your end of study visit, you will be evaluated for your disease status with imaging studies [computed tomography (CT) scans or magnetic resonance images (MRI)] and your weight and vitals signs will be measured. You will report any medications you have taken since your last visit and any side effects or blood transfusion that you have had. You will also have a final blood draw (about 3 teaspoons) for routine tests.
The total length of your involvement in this study is expected to be about 18 weeks (4 to 5 months).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palifermin | Experimental | Drug: Palifermin, Drug: Adriamycin (Doxorubicin), Drug: Ifosfamide, Drug: Vincristine, Drug: CisplatinPalifermin + Chemotherapy (Adriamycin (Doxorubicin)+ Ifosfamide (AI) or Adriamycin (Doxorubicin) + Cisplatin (AP) Regimen); Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0. AP=Doxorubicin (Adriamycin) + Cisplatin: Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Adriamycin (Doxorubicin), Drug: Ifosfamide, Drug: Vincristine, Drug: CisplatinPlacebo + Chemotherapy (AI or AP Regimen); AI = Doxorubicin (Adriamycin) + Ifosfamide: A single dose placebo prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0. AP=Doxorubicin (Adriamycin) + Cisplatin: A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with high dose doxorubicin (90 mg/m2) with ifosfamide (AI) or cisplatinum (AP) is indicated.
- Patients (male and female) with childbearing potential (defined as not post-menopausal for 12 months, negative blood pregnancy test, or no previous surgical sterilization) must use adequate birth control.
- Adequate hematologic (Absolute neutrophil count (ANC)>/= 1500/mm^3, >/= Hgb 10gm/dL, platelet count >/= 150,000/mm^3), renal (serum creatinine </= 1.5mg/dL), hepatic (serum bilirubin count </= 1.5 * normal and SGPT < 3 * normal) functions.
- Karnofsky Performance Status >/= 80.
- Signed informed consent form.
Key exclusion criteria (11 listed)
- Pregnant or lactating women.
- Patients with comorbid condition which renders patients at high risk of treatment complication.
- Patients with metastatic disease to CNS.
- Patient has uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia, acute myocardial infarction within 3 months or has uncontrolled hypertension.
- Patient has an active seizure disorder. Patients with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of antiseizure medication for the previous 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palifermin180 mcg/kg 3 days prior to chemotherapy | Drug | Palifermin |
| PlaceboSingle dose 3 days prior to chemotherapy | Drug | Placebo |
| Adriamycin (Doxorubicin)Also: Adriamycin30 mg/m^2 IV continuous infusion for 72 hours; days 0, 1, 2 (infusion completing on day 3) (total dose = 90 mg/m^2). | Drug | Palifermin, Placebo |
| Ifosfamide2.5 g/m^2 IV bolus over 3 hours, days 0,1, 2, 3 (total dose = 10 g/m^2); for patients receiving the AI Regimen. | Drug | Palifermin, Placebo |
| Vincristine2 mg IV on day 0, for patients with small cell histology receiving the AI Regimen. | Drug | Palifermin, Placebo |
| CisplatinAlso: CDDP, Platinol120 mg/m^2 on day 0, for patients receiving the AP Regimen. | Drug | Palifermin, Placebo |
Primary outcome
Cumulative Incidence Rate of Oral Mucositis
Time frame: Within 6 blinded cycles (3-week cycles), up to 18 weeks.
Cumulative incidence of World Health Organization (WHO) grade 2 or > mucositis (moderate to severe) in participants completing up to 6 blinded cycles. Rate defined as participants who had Grade 2 or > divided by total number of participants who completed up to 6 blinded cycles. WHO Criteria of Grade 1: possible buccal mucosal scalloping with/without erythema; No ulcers; swallows solid diet. Grade 2: ulcers with or without erythema; swallow solid diet. Grade 3: ulcers with/without (extensive) erythema; swallow liquid, not solid diet. Grade 4: mucositis to extent alimentation not possible.
Median Maximum Score for Patient Reported Outcomes in 2 Blinded Cycles
Time frame: Within the first 2 blinded cycles (3-week cycles), up to 6 weeks.
Median maximum score (0 to 10, with 10 being the worst) for participant-reported outcomes in the first 2 blinded cycles for Mouth Pain, Overall Mouth and Throat Soreness, and Rectal Soreness while median maximum score for Swallowing, Drinking and Eating Difficulty (0 to 4, with 4 being the difficult).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20855800Vadhan-Raj S, Trent J, Patel S, Zhou X, Johnson MM, Araujo D, Ludwig JA, O'Roark S, Gillenwater AM, Bueso-Ramos C, El-Naggar AK, Benjamin RS. Single-dose palifermin prevents severe oral mucositis during multicycle chemotherapy in patients with cancer: a randomized trial. Ann Intern Med. 2010 Sep 21;153(6):358-67. doi: 10.7326/0003-4819-153-6-201009210-00003.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saroj Vadhan-Raj, M.D. principal investigator
University of Texas MDAnderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palifermin, Adriamycin (Doxorubicin) and Ifosfamide in people with Sarcoma and Oral Mucositis, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence Rate of Oral Mucositis (time frame: Within 6 blinded cycles (3-week cycles), up to 18 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00267046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2012.