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

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

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.

Study Overview

• Status: Unknown
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: docetaxel; Drug: oxaliplatin

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 Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• France
  • Montfermeil, France, 93370
    • Intercommunal Hospital
  • Paris, France, 75970
    • Hopital Tenon
  • Paris, France, 75012
    • Hopital Saint Antoine
  • Reims, France, F-51100
    • Polyclinique de Courlancy
  • Senlis, France, 60309
    • C.H. Senlis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Maximum tolerated dose of docetaxel and oxaliplatin

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
• Investigators: Study Chair: Christophe Tournigand, Hopital Saint Antoine

Study record dates

Study Major Dates

• Study Start: July 1, 2003

Study Registration Dates

• First Submitted: January 9, 2004
• First Submitted That Met QC Criteria: January 11, 2004
• First Posted (Estimate): January 12, 2004

Study Record Updates

• Last Update Posted (Estimate): July 24, 2008
• Last Update Submitted That Met QC Criteria: July 23, 2008
• Last Verified: July 1, 2007

More Information

Terms related to this study

• Keywords: stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Oxaliplatin
• Other Study ID Numbers: CDR0000346887; FRE-GERCOR-DOCELOX/O-01-1; EU-20332