Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 to 75 Other FRE-GERCOR-DOCELOX/O-01-1 EU-20332, NCT00075543

Objectives

Primary

1. Determine the maximum tolerated dose of docetaxel and oxaliplatin in patients with stage III or IV ovarian epithelial cancer.
2. Determine the toxicity of this regimen in these patients.

Secondary

1. Determine the tolerance profile of patients treated with this regimen.
2. Determine a recommended phase III dose of this regimen in these patients.
3. Determine the efficacy of this regimen, in terms of objective response rate and radiological and biological response rate (CA 125), in these patients.
4. Determine the complete pathological response in patients treated with this regimen as first-line therapy.
5. Determine the duration of the objective response in patients treated with this regimen.
6. Determine the time to progression in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed ovarian epithelial cancer
  • Stage III or IV disease
  • Metastatic peritoneal, lymphatic, or visceral disease



• Measurable or evaluable disease



• Previously untreated disease OR relapsed disease more than 6 months after the completion of a platinum-containing chemotherapy regimen



• No symptomatic brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy
• No more than 1 prior chemotherapy regimen
• No prior oxaliplatin or docetaxel

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Not specified

Other

• More than 28 days since prior participation in another clinical study
• No other concurrent anticancer treatment

Patient Characteristics:

Age

• 18 to 75

Performance status

• WHO 0-2 (0 in patients 70 to 75 years of age)

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.25 times upper limit of normal (ULN)
• AST and ALT no greater than 3 times ULN
• Alkaline phosphatase less than 2.5 times ULN

Renal

• Creatinine no greater than 1.4 mg/dL

Other

• No serious uncontrolled infection
• No intolerance to polysorbate 80
• No peripheral neuropathy greater than grade 1
• No neurological or mental disease that would preclude study participation
• No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix

Expected Enrollment

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

Outcomes

Maximum tolerated dose of docetaxel and oxaliplatin
Toxicity

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

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.

Trial Contact Information

Trial Lead Organizations

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

Christophe Tournigand, Protocol chair		Ph: 33-1-4928-2329 Email: christophe.tournigand@sat.ap-hop-paris.fr

Registry Information
Official Title		Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer
Trial Start Date		2003-07-11
Registered in ClinicalTrials.gov		NCT00075543
Date Submitted to PDQ		2003-11-21
Information Last Verified		2007-07-16

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