Paclitaxel and Cisplatin as First-Line Treatment for Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer
Conditions
Ovarian Cancer
Conditions: official terms
Neoplasms, Glandular and Epithelial - Ovarian Neoplasms
Conditions: Keywords
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
Study Type
Interventional
Study Phase
Phase 2
Study Design
Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: cisplatin Type: Drug
Name: paclitaxel Type: Drug
Overall Status
Recruiting
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.
Detailed 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 72 Years
Minimum Age: 18 Years
Gender: Female
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
Location
Russian Academy of Medical Sciences Cancer Research Center
Moscow, Russian Federation
Status: Recruiting
Contact: Sergei A. Tjulandin, MD, PhD - 7-495-324-9874
Start Date
April 2009
Sponsors
Russian Academy of Medical Sciences Cancer Research Center
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page