Tracking Information
Start Date ICMJE | April 2009 |
---|---|
Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: August 22, 2009) | Progression-free survival [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00964626 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: August 22, 2009) |
|
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Paclitaxel and Cisplatin as First-Line Treatment for Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer |
---|---|
Official Title ICMJE | A Phase II Study of Efficacy and Safety of Paclitaxel and Cisplatin Every 2 Weeks as the First-line Treatment of Patients With Ovarian Cancer Stage Ic-IV. |
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:
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 Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Open Label |
Condition ICMJE | Ovarian Cancer |
Intervention ICMJE |
|
Recruitment Information
Estimated Enrollment ICMJE | 60 |
---|---|
Completion Date | |
Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
Gender | Female |
Ages | 18 Years to 72 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | |
Location Countries ICMJE | Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00964626 | ||||
---|---|---|---|---|---|
Responsible Party | |||||
Study ID Numbers ICMJE | CDR0000641288, USSR-AMS-PAC-2, EU-20937, BIOCAD-PAC-2 | ||||
Study Sponsor ICMJE | Russian Academy of Medical Sciences Cancer Research Center | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
| ||||
Information Provided By | National Cancer Institute (NCI) |