drugset / Trial / NCT00001426
A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer
Treatment
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.
Timeline
- Start
- 1995-02-03
- Primary completion
- 2007-10-15
- Completion
- 2013-11-07
Publications
- Background Kohn EC, Sarosy GA, Davis P, Christian M, Link CE, Ognibene FP, Sindelar WF, Jacob J, Steinberg SM, Premkumar A, Reed E. A phase I/II study of dose-intense paclitaxel with cisplatin and cyclophosphamide as initial therapy of poor-prognosis advanced-stage epithelial ovarian cancer. Gynecol Oncol. 1996 Aug;62(2):181-91. doi: 10.1006/gyno.1996.0213.
- Background Reed E, Kohn EC, Sarosy G, Dabholkar M, Davis P, Jacob J, Maher M. Paclitaxel, cisplatin, and cyclophosphamide in human ovarian cancer: molecular rationale and early clinical results. Semin Oncol. 1995 Jun;22(3 Suppl 6):90-6.
- Background Link CJ Jr, Sarosy GA, Kohn EC, Christian MC, Davis P, Adamo DO, Reed E. Cutaneous manifestations of Taxol therapy. Invest New Drugs. 1995;13(3):261-3. doi: 10.1007/BF00873811.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | — | — |
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Paclitaxel | Small molecule | — | — |
| Background | G-CSF | Unknown | — | — |