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 Sciences (RAMS)

Status and phase: Unknown; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: cisplatin; Drug: paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00964626

USSR-AMS-PAC-2

CDR0000641288

EU-20937

BIOCAD-PAC-2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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