Cancer of the Biliary Tract Clinical Trial
Official title:
A Phase II Study of Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma, Including Carcinoma of the Gallbladder and Biliary Tract
| Verified date | July 2012 |
| Source | M.D. Anderson Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | May 2009 |
| Est. primary completion date | May 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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. - 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. Exclusion Criteria: - 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. - 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | U.T. M.D. Anderson Cancer Center | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| M.D. Anderson Cancer Center | Sanofi-Synthelabo |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Baseline with restaging every 3 cycles (cycle=21 days) | No |