A phase II trial of weekly docetaxel in patients with platinum-resistant epithelial ovarian, primary peritoneal serous cancer, or fallopian tube cancer.

Abstract

OBJECTIVE:

To determine the activity and tolerability of weekly docetaxel in patients with platinum-resistant mullerian origin tumors.

METHODS:

Patients with persistent disease, or those recurring less than 6 months after receiving platinum-containing therapy, were eligible for this phase II study. Docetaxel was initially administered at a dose of 40 mg/m(2) on days 1, 8, and 15, with a cycle length of 28 days. This starting dose was subsequently reduced to 30 mg/m(2) due to toxicity. Dexamethasone prophylaxis was administered at a dose of 4 mg PO every 12 hours for 3 doses, starting 12 hours before each dose of docetaxel.

RESULTS:

Thirty-two patients were enrolled, with a median age of 59 years. The majority of patients received a median of 3 prior regimens, with 45% of the study group having received 4 or more prior regimens. The overall response rate in 29 evaluable patients was 6.9%, with no complete responses. Seventeen percent of patients experienced stable disease. Dose reduction or delay was required in 10 of the first 22 patients enrolled, prompting a reduction in the starting dose to 30 mg/m(2). Hematologic toxicity was generally tolerable, and no patient experienced febrile neutropenia. Non-hematologic toxicity was generally grade 1 in nature, although a combination of multiple low grade toxicities occurring in an individual patient oftentimes mandated dose reduction.

CONCLUSIONS:

Weekly docetaxel demonstrated modest activity in a heavily pre-treated, platinum-resistant population. A starting docetaxel dose of 30 mg/m(2) would be reasonable for future studies exploring the utility of weekly dosing in less heavily pre-treated patients.

• Authors: Anna Berkenblit, Michael V Seiden, Ursula A Matulonis, Richard T Penson, Carolyn N Krasner, Maria Roche, Lisa Mezzetti, Tina Atkinson, Stephen A Cannistra
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 95 Issue 3 Pg. 624-31 (Dec 2004) ISSN: 0090-8258 [Print] United States
• PMID: 15581974 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Phytogenic
• Organoplatinum Compounds
• Taxoids
• Docetaxel

Topics

• Aged
• Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects)
• Cystadenocarcinoma, Serous (drug therapy)
• Docetaxel
• Drug Administration Schedule
• Drug Resistance, Neoplasm
• Fallopian Tube Neoplasms (drug therapy)
• Female
• Humans
• Middle Aged
• Organoplatinum Compounds (therapeutic use)
• Ovarian Neoplasms (drug therapy)
• Peritoneal Neoplasms (drug therapy)
• Taxoids (administration & dosage, adverse effects)