Head and Neck CancerPhase 2NCT00503997
Pemetrexed and Oxaliplatin in Treating Patients With Locally Advanced Head and Neck Cancer
A Phase 2 study testing oxaliplatin and pemetrexed disodium in people with Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center at 7 sites in United States.
Trial summary
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- oxaliplatin and pemetrexed disodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2006to Jun 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria in order to be eligible for entry into the trial:
- Histologically or cytologically confirmed stage III - IVB HNSCC (includes unknown primary and ParaNasal Sinus cancers)but excludes nasopharyngeal, salivary gland or skin primaries (No TNM staging required)
- Patients must have a measurable disease defined by RECIST criteria
- Age > 18 years
- ECOG Performance Score of 0, 1 or 2
- Adequate bone marrow as evidenced by:
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- Absolute neutrophil count > 1,500/μL
- Platelet count > 100,000/μL
- Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL and CrCl > 45 mL/min as determined by calculated creatinine clearance using the Cockroft-Gault formula:
- CrCl = (140-age) x (weight in kg)/72 x serum creatinine
- Multiply by 0.85 (85%) for females
- Adequate hepatic function as evidenced by:
- Serum total bilirubin < 1.5 mg/dL
- Alkaline phosphatase < 3X the ULN for the reference lab
- SGOT/SGPT < 3X the ULN for the reference lab
- Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
- Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive, double barrier method or surgical intervention resulting in sterility).
- Patients must be able to interupt NSAIDs at 2 days before (5 days for long-acting NSAIDs),the day of, and 2 days following administration of Pemetrexed.
- Patients must be willing and able to take Folic Acid (350-1000 μg) daily beginning 1 week (7 days) prior to the first dose of Pemetrexed and continued daily until 3 weeks after the last dose of study therapy. In addition, patients must be willing to maintain a Pill Diary as part of study compliance.
- Patients must be willing and able to take Vitamin B12 (1000 μg) administered intramuscularly beginning 1 week (7 days) prior to the first dose of Pemetrexed and repeated at the planned End of Treatment visit (no later than 9 weeks from the first injection).
- Patients must be willing and able to take Dexamethasone (4 mg of oral or equivalent) that should be given twice daily on the day before, the day of, and the day after each dose of Pemetrexed for rash prophylaxis unless medically contraindicated.
Who cannot join
- A patient may not be enrolled in the trial if any of the following criteria are met:
- Patients with an active infection or with a fever > 101.30 F within 3 days of the first scheduled day of protocol treatment
- History of prior malignancy within the past 3 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry
- Patients with known hypersensitivity to any of the components of Oxaliplatin and Pemetrexed
- Patients who received any chemotherapy, radiation therapy or surgical resection other than diagnostic biopsies for HNSCC prior to the first scheduled day of protocol treatment
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment(investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
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- Peripheral neuropathy ≥ Grade 2
- Patients who are pregnant or lactating
- Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent,cooperate and participate in the study, or interferes with the interpretation of the results.
- History of allogeneic transplant
- Known HIV (active, previously treated or both)
- Presence of clinically detectable (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, 37208
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Mitchell Memorial Cancer Center at Owensboro Medical Health System
Owensboro, Kentucky, 42303
Purchase Cancer Group - Paducah
Paducah, Kentucky, 42002
About this study
Official title: Phase II Trial: Efficacy and Toxicity of Induction Pemetrexed (ALIMTA) and Oxaliplatin (ELOXATIN) in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with oxaliplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pemetrexed together with oxaliplatin works in treating patients with locally advanced head and neck cancer.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the clinical response rate in patients with locally advanced squamous cell carcinoma of the head and neck treated with neoadjuvant pemetrexed disodium and oxaliplatin.
Secondary
- To evaluate the pathological complete response in patients who undergo surgical resection or post-induction biopsy.
- To assess toxicity of therapy, including the assessment of quality of life, fatigue, and head and neck cancer-related symptoms.
- To predict response and toxicities based on pharmacogenomics, genomics, and proteomics.
OUTLINE: This is a nonrandomized, open-label study. Patients are assigned to 1 of 2 groups based on resectability of disease (resectable vs nonresectable).
- Group I (resectable disease): Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
After completion of pemetrexed disodium and oxaliplatin, patients undergo surgical resection of disease.
- Group II (nonresectable disease): Patients receive treatment as in group I. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to concurrent chemoradiotherapy.
After completion of pemetrexed disodium and oxaliplatin, patients undergo concurrent chemoradiotherapy.
Blood samples are collected at baseline and periodically during study for biomarker and pharmacokinetic studies.
Quality of life is assessed prior to each course of therapy and at 4-6 weeks after the last course.
After completion of study treatment, patients are followed periodically for up to 3 years.
- Conditions
- Head and Neck Cancer
- Being tested
- oxaliplatin, pemetrexed disodium
- Keywords
- stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, untreated metastatic squamous neck cancer with occult primary
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
Also called Eloxatin
Group I: Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
Group II: Patients receive treatment as in group I. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to concurrent chemoradiotherapy.
pemetrexed disodiumDrug
Also called Alimta
Group I: Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
Group II: Patients receive treatment as in group I. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to concurrent chemoradiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| drug therapy | Experimental | Not described Receives: Drug: oxaliplatin; Drug: pemetrexed disodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Response to Treatment Measured by RECIST Criteria
RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Measured: at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startDec 2006
- Primary completionJun 2009
- Study completionJun 2010
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 (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jill Gilbert, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Jill Gilbert, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503997
- Sponsor's protocol ID
- VICC HN 0582
- Other IDs
- VU-VICC-HN-0582, VU-VICC-IRB-060100
- Status last verified
- May 2012
- First submitted
- 17 Jul 2007
- Last updated
- 10 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chung CH, Lee JW, Slebos RJ, Howard JD, Perez J, Kang H, Fertig EJ, Considine M, Gilbert J, Murphy BA, Nallur S, Paranjape T, Jordan RC, Garcia J, Burtness B, Forastiere AA, Weidhaas JB. A 3'-UTR KRAS-variant is associated with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Ann Oncol. 2014 Nov;25(11):2230-2236. doi: 10.1093/annonc/mdu367. Epub 2014 Jul 31.
PubMed 25081901Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.
PubMed 25057165
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial: Efficacy and Toxicity of Induction Pemetrexed (ALIMTA) and Oxaliplatin (ELOXATIN) in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00503997
- Acronym / sponsor ID
- VICC HN 0582
- Conditions
- Head and Neck Cancer
- Keywords
- stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Posted 12 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with oxaliplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pemetrexed together with oxaliplatin works in treating patients with locally advanced head and neck cancer.
Detailed description
OBJECTIVES:
Primary
- To evaluate the clinical response rate in patients with locally advanced squamous cell carcinoma of the head and neck treated with neoadjuvant pemetrexed disodium and oxaliplatin.
Secondary
- To evaluate the pathological complete response in patients who undergo surgical resection or post-induction biopsy.
- To assess toxicity of therapy, including the assessment of quality of life, fatigue, and head and neck cancer-related symptoms.
- To predict response and toxicities based on pharmacogenomics, genomics, and proteomics.
OUTLINE: This is a nonrandomized, open-label study. Patients are assigned to 1 of 2 groups based on resectability of disease (resectable vs nonresectable).
- Group I (resectable disease): Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
After completion of pemetrexed disodium and oxaliplatin, patients undergo surgical resection of disease.
- Group II (nonresectable disease): Patients receive treatment as in group I. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to concurrent chemoradiotherapy.
After completion of pemetrexed disodium and oxaliplatin, patients undergo concurrent chemoradiotherapy.
Blood samples are collected at baseline and periodically during study for biomarker and pharmacokinetic studies.
Quality of life is assessed prior to each course of therapy and at 4-6 weeks after the last course.
After completion of study treatment, patients are followed periodically for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| drug therapy | Experimental | Drug: oxaliplatin, Drug: pemetrexed disodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must meet all of the following criteria in order to be eligible for entry into the trial:
- Histologically or cytologically confirmed stage III - IVB HNSCC (includes unknown primary and ParaNasal Sinus cancers)but excludes nasopharyngeal, salivary gland or skin primaries (No TNM staging required)
- Patients must have a measurable disease defined by RECIST criteria
- Age > 18 years
- ECOG Performance Score of 0, 1 or 2
Key exclusion criteria (12 listed)
- Patients with an active infection or with a fever > 101.30 F within 3 days of the first scheduled day of protocol treatment
- History of prior malignancy within the past 3 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry
- Patients with known hypersensitivity to any of the components of Oxaliplatin and Pemetrexed
- Patients who received any chemotherapy, radiation therapy or surgical resection other than diagnostic biopsies for HNSCC prior to the first scheduled day of protocol treatment
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment(investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
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 |
|---|---|---|
| oxaliplatinAlso: EloxatinGroup I: Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery. Group II: Patients receive treatment as in group I. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to concurrent chemoradiotherapy. | Drug | drug therapy |
| pemetrexed disodiumAlso: AlimtaGroup I: Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery. Group II: Patients receive treatment as in group I. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to concurrent chemoradiotherapy. | Drug | drug therapy |
Primary outcome
Patient Response to Treatment Measured by RECIST Criteria
Time frame: at 8 weeks
RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25081901Chung CH, Lee JW, Slebos RJ, Howard JD, Perez J, Kang H, Fertig EJ, Considine M, Gilbert J, Murphy BA, Nallur S, Paranjape T, Jordan RC, Garcia J, Burtness B, Forastiere AA, Weidhaas JB. A 3'-UTR KRAS-variant is associated with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Ann Oncol. 2014 Nov;25(11):2230-2236. doi: 10.1093/annonc/mdu367. Epub 2014 Jul 31.
- Derived from this study: PubMed 25057165Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.
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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.
Jill Gilbert, MD principal investigator
Vanderbilt-Ingram Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxaliplatin and pemetrexed disodium in people with Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center at 7 sites 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 21 inclusion and 12 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 10 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 7 sites 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. 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 12 Mar 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?
Patient Response to Treatment Measured by RECIST Criteria (time frame: at 8 weeks). 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 NCT00503997, which also lists 2 linked publications.
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 10 May 2012.