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EXIBIT: Oxaliplatin in Biliary Tract Cancer

A Multicentre Phase II Trial of Gemcitabine and Oxaliplatin (GEMOX) in Patients With Biliary Tract Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00174564
Enrollment
67
Registered
2005-09-15
Start date
2003-04-30
Completion date
2006-09-30
Last updated
2012-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Neoplasms

Brief summary

The primary objective is to evaluate the efficacy of the GEMOX treatment as 1st line therapy in patients with advanced biliary tract cancer based on response rate measured by the RECIST unidimensional criteria. Secondary objectives are : Progression free survival, overall survival and safety.

Interventions

DRUGoxaliplatin

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Histologically proven, locally advanced or metastatic carcinoma of the biliary tract (gallbladder, intrahepatic bile ducts, extrahepatic bile ducts, ampula of Vater) * For intrahepatic bile ducts, if the diagnosis of biliary tract origin is not evident by imaging or surgical exploration, and so equivalent to liver metastasis with unknown primary site, inclusion is possible if: * unknown primary after an exhaustive search for the primary site (chest radiography- , thoracic and abdomino pelvic CT scan, colonoscopy, oesogastroduodenal endoscopy, PSA determination for men or mammography for women, and PET scan if possible). * histological examination compatible with adenocarcinoma of bile ducts with the immunostaining expression of cytokeratin : 7+, 20- and 19 +. (Shimonishi, 2000 \^22) * No prior chemotherapy for advanced disease (first line) * No radiation therapy within 4 weeks prior to the first gemcitabine administration. * Unidimensionally measurable disease. * For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception * No known allergy to one of the study drugs * No prior malignancy * No CNS metastases * No peripheral neuropathy \> grade 2 * ECOG PS \<=2 * ANC \> 1.5 X 10\^9 /L * Platelets \> 100 X 10\^9 /L * Creatinine \< 1.5 x ULN * SGPT (ALT) \< 5 x ULN * Bilirubin \< 2.5 x ULN (patients with jaundice or evidence of bile duct obstruction and in whom the biliary tree can be decompressed by endoscopic percutaneous endoprothesis, with subsequent reduction in bilirubin \< 2.5 x ULN will be eligible for the study).

Design outcomes

Primary

MeasureTime frame
To evaluate response rate according to RECIST criteria

Secondary

MeasureTime frame
To evaluate the progression-free survival in the ITT population
To investigate safety using NCI-CTC criteria version 2

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026