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Home > "D" Clinical Trials Conditions > Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer  Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
For Condition: recurrent ovarian epithelial cancer,stage 4 ovarian epithelial cancer,stage 3 ovarian epithelial cancer
Status: Recruiting
Sponsor(s): GERCOR ,
Synopsis: 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining docetaxel with oxaliplatin in treating patients who have stage III or stage IV ovarian epithelial cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristopheTournigand, Study Chair, Hopital Saint Antoine
Intercommunal Hospital *Recruiting*
Montfermeil, , 93370
France
Recruiting Mostefa Bennamoun 33-1-4850-1808
Hopital Saint Antoine *Recruiting*
Paris, , 75012
France
Recruiting Christophe Tournigand 33-1-4928-2329
C.H. Senlis *Recruiting*
Senlis, , 60309
France
Recruiting Elisabeth Carola 33-3-4421-7000
Hopital Tenon *Recruiting*
Paris, , 75970
France
Recruiting Jean-Pierre Lotz 33-1-5601-6058
Polyclinique De Courlancy *Recruiting*
Reims, , F-51100
France
Recruiting Philippe Colin 33-3-2684-0284
Additional Information:
Study ID Numbers: CDR0000346887; FRE-GERCOR-DOCELOX/O-01-1,EU-20332
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075543
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
2. Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
3. Nitrocamptothecin in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer
4. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
5. Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer
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Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
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