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

Ovarian Cancer Clinical Trial

Official title:

Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00075543
• Other study ID #: CDR0000346887
• Secondary ID: FRE-GERCOR-DOCEL
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: January 9, 2004
• Last updated: July 23, 2008
• Start date: July 2003

Study information

• Verified date: July 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

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/mm^3

• Platelet count at least 100,000/mm^3

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

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• docetaxel

• oxaliplatin

Locations

Country	Name	City	State
France	Intercommunal Hospital	Montfermeil
France	Hopital Saint Antoine	Paris
France	Hopital Tenon	Paris
France	Polyclinique De Courlancy	Reims
France	C.H. Senlis	Senlis

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of docetaxel and oxaliplatin			Yes
Primary	Toxicity			Yes
Secondary	Tolerance profile			Yes
Secondary	Recommended phase III dose			No
Secondary	Efficacy			No
Secondary	Complete pathological response			No
Secondary	Duration of the objective response			No
Secondary	Time to progression			No