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

Phase 2
Conditions
Ovarian Cancer
Registration Number
NCT00964626
Lead Sponsor
Russian Academy of Medical Sciences
Brief 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
60
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Progression-free survival
Secondary Outcome Measures
NameTimeMethod
Overall survival
Objective response rate (complete and partial remission in patients with measurable disease)
Toxicity

Trial Locations

Locations (1)

Russian Academy of Medical Sciences Cancer Research Center

🇷🇺

Moscow, Russian Federation

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