Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma

NCT00338988 | Completed Phase 2 Results

• 1 other identifier: 2003-0340
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cancer of the Gallbladder; Cancer of the Biliary Tract

Keywords

Gastrointestinal; Capecitabine; Oxaliplatin; Carcinoma of the Gallbladder; Carcinoma of the Intrahepatic or Extrahepatic Biliary Tract; Xeloda; Eloxatin

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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.

Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Capecitabine DRUG

1500 mg/m\^2 PO twice daily x 14 days.

Also known as: Xeloda

Capecitabine + Oxaliplatin

Oxaliplatin DRUG

130 mg/m\^2 IV over 2 hours on day 1 of cycle.

Also known as: Eloxatin

Capecitabine + Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Sanofi-Synthelabo: collaborator

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Gallbladder Neoplasms; Biliary Tract Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Melanie Thomas, MD/Assistant Professor
• Organization: University Texas MD Anderson Cancer Center

mjlim@mdanderson.org

713-794-4869

Study Officials

• Melanie Thomas, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2006
• First Posted: June 20, 2006
• Study Start: August 1, 2003
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 1, 2012
• Results First Posted: December 8, 2010

Record last verified: 2012-07

Locations

US (1)