Trials Sponsors Conditions Drugs Pricing

Conditions

Cancer of the Biliary Tract Cancer of the Gallbladder

Keywords

GastrointestinalCapecitabineOxaliplatinCarcinoma of the GallbladderCarcinoma of the Intrahepatic or Extrahepatic Biliary TractXelodaEloxatin

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: CapecitabineDrug: Oxaliplatin

Interventions

CapecitabineDrug

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

Also known as: Xeloda

Capecitabine + Oxaliplatin

OxaliplatinDrug

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

Also known as: Eloxatin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Sanofi-Synthelabo
Industrycollaborator
M.D. Anderson Cancer Center
Otherlead

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

MeSH Terms

Conditions

Gallbladder NeoplasmsBiliary Tract Neoplasms

Interventions

CapecitabineOxaliplatin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine Nucleosides

Results Point of Contact

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

Study Officials

Melanie Thomas, MD
M.D. Anderson Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes
Restrictive Agreement: No

Enrollment

44 participants (actual enrollment reported by the registry).

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 2003

Date type not reported

This date has not been verified as actual or estimated.

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.

Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Capecitabine + Oxaliplatin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Capecitabine + Oxaliplatin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations