Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer

Phase 1

• Conditions: Ovarian Cancer

• Registration Number: NCT00075543
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel and oxaliplatin and to see how well they work in treating patients with stage III or stage IV ovarian epithelial cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of docetaxel and oxaliplatin in patients with stage III or IV ovarian epithelial cancer.

* Determine the toxicity of this regimen in these patients.

Secondary

* Determine the tolerance profile of patients treated with this regimen.

* Determine a recommended phase III dose of this regimen in these patients.

* Determine the efficacy of this regimen, in terms of objective response rate and radiological and biological response rate (CA 125), in these patients.

* Determine the complete pathological response in patients treated with this regimen as first-line therapy.

* Determine the duration of the objective response in patients treated with this regimen.

* Determine the time to progression in patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 3 months.

PROJECTED ACCRUAL: A total of 30-39 patients will be accrued for this study.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2004-01-09
• Study First Submitted QC: 2004-01-11
• Study First Posted: 2004-01-12
• Status Verified: 2007-07
• Last Update Submitted: 2008-07-23
• Last Update Posted: 2008-07-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicity
Maximum tolerated dose of docetaxel and oxaliplatin

Secondary Outcome Measures

Name	Time	Method
Tolerance profile
Recommended phase III dose
Efficacy
Duration of the objective response
Complete pathological response
Time to progression

Trial Locations

Locations (5)

C.H. Senlis; 🇫🇷 Senlis, France

Hopital Saint Antoine; 🇫🇷 Paris, France

Intercommunal Hospital; 🇫🇷 Montfermeil, France

Hopital Tenon; 🇫🇷 Paris, France

Polyclinique De Courlancy; 🇫🇷 Reims, France