Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer

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. It is not yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer. PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.

Timeline

Start

1998-10

Primary completion

2010-03

Completion

—

Outcome

Missed primary endpoint

paper Maintenance paclitaxel at 40 mg/m²/week × 24 weeks added to standard dose AUC6 and paclitaxel 175 mg/m² × 3 doses provides no significant increase in RFI. PMID 21529904 ↗

Publications

• Results Mannel RS, Brady MF, Kohn EC, Hanjani P, Hiura M, Lee R, Degeest K, Cohn DE, Monk BJ, Michael H. A randomized phase III trial of IV carboplatin and paclitaxel x 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients with early-stage ovarian carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2011 Jul;122(1):89-94. doi: 10.1016/j.ygyno.2011.03.013. Epub 2011 May 6.

Drugs

Indications