Paclitaxel and Cisplatin as First-Line Treatment for Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving paclitaxel together with cisplatin as first-line therapy and to see how well it works in treating patients with stage I, stage II, stage III, or stage IV ovarian epithelial cancer.

Detailed Description
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OBJECTIVES: To investigate the efficacy and safety of paclitaxel and cisplatin as first-line chemotherapy in patients with stage IC-IV ovarian epithelial cancer. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV and cisplatin IV once every 2 weeks. Treatment repeats every 2 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.

Official Title
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A Phase II Study of Efficacy and Safety of Paclitaxel and Cisplatin Every 2 Weeks as the First-line Treatment of Patients With Ovarian Cancer Stage Ic-IV.

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed epithelial adenocarcinoma of the ovary Stage IC-IV disease No known or clinical evidence of brain metastasis PATIENT CHARACTERISTICS: ECOG performance status 0-2 Hemoglobin must be ≥ 90 g/L ANC ≥ 2 x 10^9/L Platelet count ≥ 100 x10^9/L Serum creatinine ≤ 115 μmol/L Total bilirubin ≤ 25 μmol/L Not pregnant or nursing No other serious disease which could affect protocol compliance and results No other prior malignancy within the past 5 years except for curatively treated carcinoma in situ of the cervix or squamous carcinoma of the skin No peripheral neuropathy ≥ CTCAE version 3.0 grade 2 No known hypersensitivity to any of the study drugs or their excipients No drug addiction or alcoholism No disorder which leads to the condition that contraindicates the use of the investigational drugs, or that may affect the patient's compliance with the study requirements PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy for ovarian cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Objective response rate (complete and partial remission in patients with measurable disease) |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IA ovarian epithelial cancer, stage IB ovarian epithelial cancer, stage IC ovarian epithelial cancer, stage IIA ovarian epithelial cancer, stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer