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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Russian Academy of Medical Sciences
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

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