Phase II study of gemcitabine in recurrent platinum-and paclitaxel-resistant ovarian cancer.

Abstract

OBJECTIVE:

To determine the activity and tolerability of gemcitabine in the palliative treatment of ovarian cancer.

METHODS:

Patients affected by ovarian cancer, and with progressive disease after treatment with platinum/paclitaxel-based chemotherapy, were enrolled into this phase II study. Gemcitabine, 1000 mg/m(2), was administered on days 1, 8, and 15, by 30-min intravenous infusion. Cycles were repeated every 28 days.

RESULTS:

Fifty patients were enrolled. All the patients were platinum and/or paclitaxel resistant (median number of previous regimens, 2; range, 1-5). Median platinum-free interval was 3 (range, 1-11) months and median paclitaxel-free interval was 6 (range, 1-36) months. A total of 210 courses were evaluable for toxicity, with a median number of four cycles administered per patient (range, 1-10). A grade 3 or 4 hematological toxicity was observed in 27 patients (54%) (anemia grade 3, 16%; grade 4, 2%; neutropenia grade 3, 24%; grade 4, 18%; thrombocytopenia grade 3, 8%; grade 4, 0%). A 20-50% dose reduction was required for 36 patients (72%, 55% of cycles). Blood transfusions were necessary for 15 patients (30%), while 2 (4%) were treated with erythropoetin. Granulocyte colony-stimulating factor was necessary in 4 patients (8%). Nonhematological toxicity was mild and manageable. Only 4 patients (8%) experienced a grade 3 hepatic toxicity (elevated liver enzymes). Forty-one patients (82%) are, so far, evaluable for response. Among them, 7 partial responses (17%; 95% confidence interval [CI], 6-29), 15 disease stabilizations (>16 weeks) (36.6%; 95% CI, 21.9-51.3), and 19 progressions (46.3%; 95% CI, 31.0-61.6) have been registered. An overall clinical benefit was observed in 53.7% of patients. Thirteen patients (31.7%) had a time-to-progression exceeding 24 weeks.

CONCLUSIONS:

This study confirms the activity and safety of gemcitabine in heavily pretreated patients with recurrent ovarian cancer.

• Authors: Giuseppe D'Agostino, Frederic Amant, Patrick Berteloot, Giovanni Scambia, Ignace Vergote
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 88 Issue 3 Pg. 266-9 (Mar 2003) ISSN: 0090-8258 [Print] United States
• PMID: 12648573 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Antimetabolites, Antineoplastic
• Organoplatinum Compounds
• Deoxycytidine
• Paclitaxel
• Gemcitabine

Topics

• Adult
• Aged
• Aged, 80 and over
• Antimetabolites, Antineoplastic (adverse effects, therapeutic use)
• Deoxycytidine (adverse effects, analogs & derivatives, therapeutic use)
• Drug Administration Schedule
• Drug Resistance, Multiple
• Drug Resistance, Neoplasm
• Female
• Humans
• Infusions, Intravenous
• Middle Aged
• Organoplatinum Compounds (pharmacology)
• Ovarian Neoplasms (drug therapy)
• Paclitaxel (pharmacology)
• Salvage Therapy
• Gemcitabine