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

NCT00075543UNKNOWNPHASE1, PHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Start Date

2003-07-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

docetaxeloxaliplatin

Conditions

Ovarian Cancer

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Maximum tolerated dose of docetaxel and oxaliplatin

Toxicity

Secondary Outcomes

Tolerance profile

Recommended phase III dose

Efficacy

Complete pathological response

Duration of the objective response

Time to progression

Locations

Intercommunal Hospital, Montfermeil, France

Hopital Saint Antoine, Paris, France

Hopital Tenon, Paris, France

Polyclinique De Courlancy, Reims, France

C.H. Senlis, Senlis, France

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