Cancer of the GallbladderPhase 2NCT00338988
Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma
A Phase 2 study testing Capecitabine and Oxaliplatin in people with Cancer of the Gallbladder and Cancer of the Biliary Tract, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This is a Phase II trial of the combination of oxaliplatin (Eloxatin) and capecitabine (Xeloda), known as XELOX, in participants with unresectable or recurrent cholangiocarcinoma, including carcinoma of the gallbladder or biliary tract, both intrahepatic and extrahepatic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Gallbladder, Cancer of the Biliary Tract
- What is being tested?
- Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically confirmed carcinoma of the gallbladder, intrahepatic or extrahepatic biliary tract, not amenable to resection with curative intent.
- Participants must have measurable disease as per the modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria, defined as at least one lesion that can be accurately measured in at least one dimension, with minimum lesion size equal to or more than twice the slice thickness of the imaging study used.
- Participants who are previously untreated as well as those who have received prior therapy are eligible to participate in this study. Participants may have received up to a total of two prior chemotherapy regimens for their disease, including biologic therapy(ies). The same regimen may have been received at different times during the course of the Participant's treatment. Surgery, radiofrequency ablation, external beam radiotherapy, or other directed therapies do not count as prior regimens and are allowed.
- Previous treatment may include systemic chemotherapy, however, prior capecitabine (unless administered as a radiosensitizing agent concurrently with prior external beam radiotherapy) or oxaliplatin are excluded.
- If radiation was previously received, the measurable disease must be recurrent or metastatic disease outside the previous radiation field.
- A minimum of 4 weeks must have elapsed since completion of any prior chemotherapy or radiotherapy.
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- Participants should have a life expectancy of at least 16 weeks based on the clinical judgment of the Investigator.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 2 or Karnofsky > 70.
- Adequate bone marrow function defined as absolute peripheral granulocyte count of >/= 1500/mm3, platelet count >/= 100,000/ mm3, and hemoglobin >/= 10 gm/dL.
- Adequate renal function, defined as serum creatinine </= 1.5 times ULN institutional normal and calculated creatinine clearance >30 mL/min (using Cockcroft and Gault formula).
- Participants must have adequate hepatic function: total bilirubin </= 2.0 gm/dL; serum albumin >/= 2.5 gm/dL; transaminases up to 5 times the upper limit of institutional normal value; or prothrombin time prolonged up to 2 seconds greater than the institutional normal value.
- Negative serum pregnancy test in women with childbearing potential.
- The effects of the combination of oxaliplatin and capecitabine on the developing fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately.
- Participants must sign an Informed Consent and Authorization indicating that they are aware of the investigational nature of this study and the known risks involved.
- Age >/=18 years.
- Participants taking therapeutic dose-levels of coumarin-derivate anticoagulants should be switched to low Low molecular weight heparin (LMWH). Low-dose coumadin (e.g. 1 mg po per day) in Participants with in-dwelling venous access devices, is allowed.
Who cannot join
- Prior therapy with oxaliplatin or capecitabine; capecitabine administered as a radiosensitizing agent concurrently with prior external beam radiotherapy is allowable.
- Participants who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Participants may not be receiving any other investigational agents nor have received any investigational drug </= 30 days prior to enrollment.
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical therapy affecting absorption.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Because Participants with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive Participants receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with XELOX. Appropriate studies will be undertaken in Participants receiving combination anti-retroviral therapy when indicated.
- Participants with extensive symptomatic fibrosis of the lungs.
- Peripheral neuropathy > grade 1.
- Known DPD deficiency.
- Participants receiving therapeutic doses of coumarin-derivative anticoagulant therapy are excluded since a drug interaction between capecitabine and coumarin anticoagulants has been reported. Participants requiring anticoagulation who may be safely switched to LMWH are eligible.
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 of Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma, Including Carcinoma of the Gallbladder and Biliary Tract
This is a Phase II trial of the combination of oxaliplatin (Eloxatin) and capecitabine (Xeloda), known as XELOX, in participants with unresectable or recurrent cholangiocarcinoma, including carcinoma of the gallbladder or biliary tract, both intrahepatic and extrahepatic. Participants may be either previously untreated or treated with chemotherapy. Participants will accrue to two strata based on pre-treatment status; separate response rates and statistical operating characteristics will be applied to each stratum.
The primary objective is to determine the objective response rate (complete plus partial) of XELOX in this population.
Secondary objectives include determining toxicity, stable disease rates, and median and overall survival of participants treated with this combination.
Read the detailed description
Oxaliplatin causes death of cancer cells and other actively dividing cells by interfering with DNA function. Capecitabine causes death of cancer cells by interfering with certain molecules that are important in cell division.
After the screening portion of the study, if you are eligible to continue, you will begin treatment with oxaliplatin and capecitabine. Once treatment begins, you will come to M. D. Anderson at least every three weeks (21 days) for treatment. Each 21-day period of treatment is called a "cycle" of therapy. You will receive at least 3 cycles of therapy unless side effects are severe or the cancer grows very quickly.
You will need to have a small tube (central venous line) inserted into a large vein under the skin of the chest or through a vein in the arm to receive oxaliplatin. The central venous line will remain in place the entire time you are taking part in this study. Oxaliplatin must be given at M. D. Anderson. On Day 1 of each cycle, you will receive oxaliplatin injected into a vein over 2 hours.
You will take capecitabine tablets by mouth 2 times a day for the first 2 weeks (Days 1-14) of each 3-week cycle. No treatment will be given for the last 7 days of each cycle (except if your first dose of capecitabine for a new cycle is taken in the evening, your last dose will be taken in the morning of Day 15.) You must take capecitabine within 30 minutes after breakfast and dinner. The morning and evening doses should be about 12 hours apart. You should take capecitabine with water, and not with fruit juices. At the first treatment visit and every 3 weeks, you will receive enough capecitabine to last until the next visit. At each visit, you must return any capecitabine you have not used as well as all empty bottles.
Before each new cycle of therapy, you will have a complete physical exam and blood (about 2 ½ teaspoons) will be collected for routine tests. You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced. During the first cycle, you will have a blood (about 2 teaspoons) sample collected each week for routine tests. You will also have either CT scans or a MRI of the tumor(s) every 9 weeks and at the end of the study. Additional tests may be done during the study if your doctor feels it is necessary for your care.
If you experience severe side effects, treatment may be delayed, stopped, or you may receive smaller doses of the treatment. You may continue to receive treatment on this study until the disease gets worse or you experience any intolerable side effects. If this happens, you will be taken off the study and your doctor will discuss other treatment options with you.
When you stop taking part in the study, you will have blood (about 3 teaspoons) collected for routine tests. You will have a physical exam and either a CT scan or a MRI to check on the status of the disease. You will be contacted by phone every three months for the rest of your life to check on the status of the disease and on any symptoms you may be experiencing.
All tests before each new cycle of treatment and when treatment stops must be done at M. D. Anderson.
This is an investigational study. The drugs oxaliplatin and capecitabine are FDA approved for treatment of advanced cancer of the colon or rectum. However, the drugs are not approved for gallbladder or biliary tract cancer. Up to 50 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Being tested
- Capecitabine, Oxaliplatin
- Keywords
- Gastrointestinal, Capecitabine, Oxaliplatin, Carcinoma of the Gallbladder, Carcinoma of the Intrahepatic or Extrahepatic Biliary Tract, Xeloda, Eloxatin
- Medical subject headings
- Gallbladder Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
1500 mg/m^2 PO twice daily x 14 days.
OxaliplatinDrug
Also called Eloxatin
130 mg/m^2 IV over 2 hours on day 1 of cycle.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine + Oxaliplatin | Experimental | Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral (PO) capecitabine 750 mg/m^2 twice daily (total daily dose 1500 mg/m2) on Days 1-14. Receives: Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Objective Response
Objective Response = Complete Response + Partial Response. Response evaluated using modification of new international criteria proposed by RECIST [changes in only largest diameter (unidimensional measurement) of tumor lesions used in the RECIST criteria]. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Measured: Baseline with restaging every 3 cycles (cycle=21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startAug 2003
- Primary completionMay 2009
- Study completionMay 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.
- Other trials for Cancer of the GallbladderStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Responsible party
- Sponsor
- Investigators
- Melanie Thomas, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338988
- Sponsor's protocol ID
- 2003-0340
- Status last verified
- Jul 2012
- First submitted
- 16 Jun 2006
- Last updated
- 1 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma, Including Carcinoma of the Gallbladder and Biliary Tract
- ClinicalTrials.gov ID
- NCT00338988
- Acronym / sponsor ID
- 2003-0340
- Keywords
- Gastrointestinal, Capecitabine, Oxaliplatin, Carcinoma of the Gallbladder, Carcinoma of the Intrahepatic or Extrahepatic Biliary Tract, Xeloda, Eloxatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Study start
- Aug 2003
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Posted 8 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II trial of the combination of oxaliplatin (Eloxatin) and capecitabine (Xeloda), known as XELOX, in participants with unresectable or recurrent cholangiocarcinoma, including carcinoma of the gallbladder or biliary tract, both intrahepatic and extrahepatic. Participants may be either previously untreated or treated with chemotherapy. Participants will accrue to two strata based on pre-treatment status; separate response rates and statistical operating characteristics will be applied to each stratum.
The primary objective is to determine the objective response rate (complete plus partial) of XELOX in this population.
Secondary objectives include determining toxicity, stable disease rates, and median and overall survival of participants treated with this combination.
Detailed description
Oxaliplatin causes death of cancer cells and other actively dividing cells by interfering with DNA function. Capecitabine causes death of cancer cells by interfering with certain molecules that are important in cell division.
After the screening portion of the study, if you are eligible to continue, you will begin treatment with oxaliplatin and capecitabine. Once treatment begins, you will come to M. D. Anderson at least every three weeks (21 days) for treatment. Each 21-day period of treatment is called a "cycle" of therapy. You will receive at least 3 cycles of therapy unless side effects are severe or the cancer grows very quickly.
You will need to have a small tube (central venous line) inserted into a large vein under the skin of the chest or through a vein in the arm to receive oxaliplatin. The central venous line will remain in place the entire time you are taking part in this study. Oxaliplatin must be given at M. D. Anderson. On Day 1 of each cycle, you will receive oxaliplatin injected into a vein over 2 hours.
You will take capecitabine tablets by mouth 2 times a day for the first 2 weeks (Days 1-14) of each 3-week cycle. No treatment will be given for the last 7 days of each cycle (except if your first dose of capecitabine for a new cycle is taken in the evening, your last dose will be taken in the morning of Day 15.) You must take capecitabine within 30 minutes after breakfast and dinner. The morning and evening doses should be about 12 hours apart. You should take capecitabine with water, and not with fruit juices. At the first treatment visit and every 3 weeks, you will receive enough capecitabine to last until the next visit. At each visit, you must return any capecitabine you have not used as well as all empty bottles.
Before each new cycle of therapy, you will have a complete physical exam and blood (about 2 ½ teaspoons) will be collected for routine tests. You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced. During the first cycle, you will have a blood (about 2 teaspoons) sample collected each week for routine tests. You will also have either CT scans or a MRI of the tumor(s) every 9 weeks and at the end of the study. Additional tests may be done during the study if your doctor feels it is necessary for your care.
If you experience severe side effects, treatment may be delayed, stopped, or you may receive smaller doses of the treatment. You may continue to receive treatment on this study until the disease gets worse or you experience any intolerable side effects. If this happens, you will be taken off the study and your doctor will discuss other treatment options with you.
When you stop taking part in the study, you will have blood (about 3 teaspoons) collected for routine tests. You will have a physical exam and either a CT scan or a MRI to check on the status of the disease. You will be contacted by phone every three months for the rest of your life to check on the status of the disease and on any symptoms you may be experiencing.
All tests before each new cycle of treatment and when treatment stops must be done at M. D. Anderson.
This is an investigational study. The drugs oxaliplatin and capecitabine are FDA approved for treatment of advanced cancer of the colon or rectum. However, the drugs are not approved for gallbladder or biliary tract cancer. Up to 50 participants will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine + Oxaliplatin | Experimental | Drug: Capecitabine, Drug: OxaliplatinCombination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral (PO) capecitabine 750 mg/m^2 twice daily (total daily dose 1500 mg/m2) on Days 1-14. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participants must have histologically confirmed carcinoma of the gallbladder, intrahepatic or extrahepatic biliary tract, not amenable to resection with curative intent.
- Participants must have measurable disease as per the modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria, defined as at least one lesion that can be accurately measured in at least one dimension, with minimum lesion size equal to or more than twice the slice thickness of the imaging study used.
- Participants who are previously untreated as well as those who have received prior therapy are eligible to participate in this study. Participants may have received up to a total of two prior chemotherapy regimens for their disease, including biologic therapy(ies). The same regimen may have been received at different times during the course of the Participant's treatment. Surgery, radiofrequency ablation, external beam radiotherapy, or other directed therapies do not count as prior regimens and are allowed.
- Previous treatment may include systemic chemotherapy, however, prior capecitabine (unless administered as a radiosensitizing agent concurrently with prior external beam radiotherapy) or oxaliplatin are excluded.
- If radiation was previously received, the measurable disease must be recurrent or metastatic disease outside the previous radiation field.
Key exclusion criteria (11 listed)
- Prior therapy with oxaliplatin or capecitabine; capecitabine administered as a radiosensitizing agent concurrently with prior external beam radiotherapy is allowable.
- Participants who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Participants may not be receiving any other investigational agents nor have received any investigational drug </= 30 days prior to enrollment.
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical therapy affecting absorption.
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 |
|---|---|---|
| CapecitabineAlso: Xeloda1500 mg/m^2 PO twice daily x 14 days. | Drug | Capecitabine + Oxaliplatin |
| OxaliplatinAlso: Eloxatin130 mg/m^2 IV over 2 hours on day 1 of cycle. | Drug | Capecitabine + Oxaliplatin |
Primary outcome
Number of Participants With Objective Response
Time frame: Baseline with restaging every 3 cycles (cycle=21 days)
Objective Response = Complete Response + Partial Response. Response evaluated using modification of new international criteria proposed by RECIST [changes in only largest diameter (unidimensional measurement) of tumor lesions used in the RECIST criteria]. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Melanie Thomas, MD principal investigator
M.D. Anderson 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 Capecitabine and Oxaliplatin in people with Cancer of the Gallbladder and Cancer of the Biliary Tract, 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 16 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 1 Aug 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. 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 8 Dec 2010). 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?
Number of Participants With Objective Response (time frame: Baseline with restaging every 3 cycles (cycle=21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2012.