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Protocol Number:
95-C-0055
- Title:
A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin with G-CSF for Patients with Newly Diagnosed Advanced Stage Ovarian Cancer
- Number:
95-C-0055
- Summary:
A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
- Sponsoring Institute:
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National Cancer Institute (NCI)
- Recruitment Detail
- Type:
Completed Study; data analyses ongoing
- Gender:
Female
- Referral Letter Required:
Yes
- Population Exclusion(s):
Male
Children
- Eligibility Criteria:
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Special Instructions:
Many protocols are potentially hazardous, are intended only for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this protocol should be consulted before using this protocol. Dose and schedule modifications are required for patients who develop gastrointestinal, hematologic, neurologic, and biochemical (renal, hepatic, etc.) and/or other abnormalities after the administration of therapy. Additionally, Federal regulations for the protection of human subjects require approval of clinical trials by your local Institutional Review Board.
- Keyword(s):
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Ovarian Cancer
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Initial Therapy
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Paclitaxel
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Cisplatin
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Cyclophosphamide
- Recruitment Keyword(s):
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None
- Condition(s):
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Ovarian Neoplasm
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Interventions:
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Drug: Cyclophosphamide
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Drug: Paclitaxel
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Drug: Cisplatin
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Drug: G-CSF
- Supporting Site:
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National Cancer Institute
- Contact(s):
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This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Citation(s):
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A phase I/II study of dose-intense paclitaxel with cisplatin and cyclophosphamide as initial therapy of poor-prognosis advanced-stage epithelial ovarian cancer
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Paclitaxel (Taxol), cisplatin and cyclophosphamide in human ovarian cancer: molecular rationale and early clinical results
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Cutaneous manifestations of Taxol therapy
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008
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