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

Russian Academy of Medical Sciences60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 72 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Progression-free survival

Secondary Outcomes

Overall survival

Objective response rate (complete and partial remission in patients with measurable disease)

Toxicity