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A Phase II Study of Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma, Including Carcinoma of the Gallbladder and Biliary Tract

Phase 2
18 Years
Not Enrolling
Cancer of the Gallbladder, Cancer of the Biliary Tract

Thank you

Trial Information

A Phase II Study of Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma, Including Carcinoma of the Gallbladder and Biliary Tract

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

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

All tests before each new cycle of treatment and when treatment stops must be done at M. D.

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.

Inclusion Criteria:

- Participants must have histologically confirmed carcinoma of the gallbladder,
intrahepatic or extrahepatic biliary tract, not amenable to resection with curative

- 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

- 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

- 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

- 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 normal and calculated creatinine clearance >30 mL/min (using Cockcroft and Gault

- Participants must have adequate hepatic function: total bilirubin 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

Exclusion Criteria:

- Prior therapy with oxaliplatin or capecitabine; capecitabine administered as a
radiosensitizing agent concurrently with prior external beam radiotherapy is

- 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
- 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

- 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.

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Objective Response

Outcome Description:

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.

Outcome Time Frame:

Baseline with restaging every 3 cycles (cycle=21 days)

Safety Issue:


Principal Investigator

Melanie Thomas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2003

Completion Date:

May 2009

Related Keywords:

  • Cancer of the Gallbladder
  • Cancer of the Biliary Tract
  • Gastrointestinal
  • Capecitabine
  • Oxaliplatin
  • Carcinoma of the Gallbladder
  • Carcinoma of the Intrahepatic or Extrahepatic Biliary Tract
  • Xeloda
  • Eloxatin
  • Gallbladder Neoplasms
  • Cholangiocarcinoma
  • Biliary Tract Neoplasms



U.T. M.D. Anderson Cancer Center Houston, Texas  77030