Phase II study of gemcitabine and weekly paclitaxel in recurrent platinum-resistant ovarian cancer.
OBJECTIVE
The purpose of this study is to evaluate the activity of gemcitabine and weekly paclitaxel in patients with platinum-resistant ovarian cancer.


METHODS
Thirty-five patients with platinum-resistant disease and prior treatment with paclitaxel received treatment with paclitaxel 80 mg/m(2) IV over 60 min, followed by gemcitabine 1000 mg/m(2) IV administered on days 1, 8, and 15. Cycles were repeated every 4 weeks.


RESULTS
All patients had platinum-resistant disease and all had received prior treatment with paclitaxel. Patients were heavily pretreated as the median number of chemotherapy regimens for recurrent disease was 2 (0-3). The overall response rate was 40% (95% confidence intervals (24%, 58%) and 37% of patients achieved stable disease. The median time to progression was 5.7 months (95% CI, 4.6, 8.5) and median overall survival 13.1 months (95% CI, 10.6, 15.9). More than 50% of patients were alive at 12 months, including six patients (17%) who were alive at 24 months. Treatment was well tolerated. Grades 3-4 neutropenia occurred in 17 patients (48.5%), grade 3 thrombocytopenia in 7 (20%), grade 3 anemia in 3 (8.5%). The most common serious non-hematological toxicities were nausea (14%), vomiting (14%), and fatigue (34%).


CONCLUSIONS
The regimen of weekly paclitaxel and gemcitabine exhibits significant activity in heavily pretreated patients, is well tolerated, and is associated with encouraging survival. This regimen should be considered as a treatment option in patients with chemotherapy-resistant ovarian cancer.
Garcia
Agustin A
AA
University of Southern California, Keck School of Medicine, Kenneth Norris Comprehensive Cancer Center, Los Angeles, CA 90033, USA. Agustin.Garcia@cshs.org
O'Meara
Anne
A
Bahador
Ashim
A
Facio
Grace
G
Jeffers
Susan
S
Kim
Dae-Young
DY
Roman
Lynda
L
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D000093542:Gemcitabine
D009944:Organoplatinum Compounds; D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine