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

Primary Purpose

Ovarian Cancer

Status
Unknown status
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
docetaxel
oxaliplatin
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Intercommunal Hospital
  • Hopital Saint Antoine
  • Hopital Tenon
  • Polyclinique De Courlancy
  • C.H. Senlis

Outcomes

Primary Outcome Measures

Maximum tolerated dose of docetaxel and oxaliplatin
Toxicity

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2004
Last Updated
July 23, 2008
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00075543
Brief Title
Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
Official Title
Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Primary Outcome Measure Information:
Title
Maximum tolerated dose of docetaxel and oxaliplatin
Title
Toxicity
Secondary Outcome Measure Information:
Title
Tolerance profile
Title
Recommended phase III dose
Title
Efficacy
Title
Complete pathological response
Title
Duration of the objective response
Title
Time to progression

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Tournigand
Organizational Affiliation
Hopital Saint Antoine
Official's Role
Study Chair
Facility Information:
Facility Name
Intercommunal Hospital
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Polyclinique De Courlancy
City
Reims
ZIP/Postal Code
F-51100
Country
France
Facility Name
C.H. Senlis
City
Senlis
ZIP/Postal Code
60309
Country
France

12. IPD Sharing Statement

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

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