Phase 2 trial of single agent docetaxel in platinum and paclitaxel-refractory ovarian cancer, fallopian tube cancer, and primary carcinoma of the peritoneum.

Abstract

OBJECTIVE:

Previously reported data have suggested the lack of complete cross-resistance between docetaxel and paclitaxel in ovarian cancer. We wished to evaluate the biological and clinical activity of docetaxel in a patient population with well-characterized platinum and paclitaxel-refractory ovarian cancer.

METHODS:

In this single-institution phase 2 trial, 30 women with advanced ovarian cancer whose disease had either failed to respond to primary platinum-paclitaxel chemotherapy or where the cancer had progressed within 3 months of their last treatment with both a platinum agent and paclitaxel were treated with single agent docetaxel (75 mg/m(2) q 3 weeks). Due to a prior history of excessive chemotherapy-induced neutropenia, 3 patients initiated treatment at a dose of 60 mg/m(2).

RESULTS:

The median number of courses of docetaxel delivered on this protocol was 3 (range 1-7), with 7 patients requiring dose reductions due to treatment-related side effects. The most common toxicities included grade 4 neutropenia, neutropenic fever, and grade >/=2 fatigue experienced by 9 (30%), 2 (7%), 5 (17%) patients, respectively. Three patients (10%) achieved both an objective response (by CA-125 criteria) and symptomatic improvement (e.g., decrease in pain and ascites). The durations of responses were 3, 4, and 6 months.

CONCLUSION:

Single-agent docetaxel has modest, but definite activity in patients with well-characterized platinum and paclitaxel-resistant ovarian cancer. Use of this drug should be considered a rational management approach in appropriately selected patients in this clinical setting.

• Authors: Maurie Markman, Kristine Zanotti, Kenneth Webster, Gertrude Peterson, Barbara Kulp, Jerome Belinson
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 91 Issue 3 Pg. 573-6 (Dec 2003) ISSN: 0090-8258 [Print] United States
• PMID: 14675679 (Publication Type: Journal Article)

Chemical References

• Antineoplastic Agents, Phytogenic
• Taxoids
• Docetaxel
• Carboplatin
• Paclitaxel
• Cisplatin

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Phytogenic (therapeutic use)
• Carboplatin (administration & dosage)
• Cisplatin (pharmacology)
• Docetaxel
• Drug Resistance, Neoplasm
• Fallopian Tube Neoplasms (drug therapy)
• Female
• Humans
• Middle Aged
• Ovarian Neoplasms (drug therapy)
• Paclitaxel (pharmacology)
• Peritoneal Neoplasms (drug therapy)
• Taxoids (adverse effects, therapeutic use)