Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer

Phase 2

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00274859
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with metastatic cancer who cannot receive anthracycline or taxane therapy.

Detailed Description

OBJECTIVES:

Primary

* Determine the objective response rate in patients with metastatic cancer not amenable to anthracycline or taxane therapy treated with gemcitabine hydrochloride and oxaliplatin.

Secondary

* Determine the clinical benefit and tolerability of this regimen in these patients.

* Determine the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-01-10
• Study First Submitted QC: 2006-01-10
• Study First Posted: 2006-01-11
• Status Verified: 2007-05
• Last Update Submitted: 2008-07-23
• Last Update Posted: 2008-07-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate

Secondary Outcome Measures

Name	Time	Method
Clinical benefit
Tolerability
Progression-free
Overall survival

Trial Locations

Locations (14)

Hopital Saint Antoine; 🇫🇷 Paris, France

Hopital Tenon; 🇫🇷 Paris, France

C.H.G. Beauvais; 🇫🇷 Beauvais, France

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz; 🇫🇷 Besancon, France

Centre Hospitalier de Saint-Quentin; 🇫🇷 Saint-Quentin, France

Intercommunal Hospital; 🇫🇷 Montfermeil, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer; 🇫🇷 Toulon - Cedex, France

C.H. Senlis; 🇫🇷 Senlis, France

Centre Hospitalier Docteur Duchenne; 🇫🇷 Boulogne Sur Mer, France

Polyclinique De Courlancy; 🇫🇷 Reims, France

Centre Rene Huguenin; 🇫🇷 Saint Cloud, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France