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| Tracking Information | |||||
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| First Received Date ICMJE | July 11, 2001 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | February 1995 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00019045 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Combination Chemotherapy in Treating Patients With Ovarian Cancer | ||||
| Official Title ICMJE | A PHASE II STUDY OF CYCLOPHOSPHAMIDE, PACLITAXEL, CISPLATIN WITH G-CSF FOR PATIENTS WITH NEWLY DIAGNOSED ADVANCED STAGE OVARIAN CANCER | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cisplatin, cyclophosphamide, and paclitaxel plus filgrastim in treating patients with newly-diagnosed and resected stage III ovarian cancer or stage IV ovarian epithelial cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients receive cyclophosphamide IV over 15 minutes followed immediately by paclitaxel IV over 24 hours on day 1. Cisplatin IV over 1 hour is administered on day 2 for 6 courses only. Filgrastim (G-CSF) is administered subcutaneously on days 3-11. Treatment repeats every 21 days for at least 6 courses. Patients who achieve a complete response proceed to laparoscopy or second look laparotomy, then receive 2 more courses of chemotherapy. Patients with partial response or stable disease continue to receive cyclophosphamide and paclitaxel, with restaging every 2 courses. Patients with bulky residual disease proceed to interim debulking surgery after 8 courses of chemotherapy. Patients are followed every 3 months for 3 years, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: Approximately 80 patients will be accrued for this study. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00019045 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000064075, NCI-95-C-0055, NCI-CPB-349, NCI-T94-0162N | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | January 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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