A phase II trial of oral capecitabine in patients with platinum--and taxane--refractory ovarian, fallopian tube, or peritoneal cancer.
OBJECTIVE
To determine the efficacy, toxicity, and quality of life of capecitabine (Xeloda), an oral 5-fluorouracil derivative, in patients with chemorefractory recurrent mullerian cancers.


METHODS
Patients with chemorefractory persistent or recurrent ovarian, fallopian tube, or peritoneal cancer with measurable disease were enrolled. Capecitabine was administered beginning at 2000 mg/m2/day orally in two divided doses with meals on a 21-day cycle: 14 days of capecitabine followed by a 7-day rest period. One dose escalation or reduction was allowed. Response was assessed after cycle 2 and cycle 4 and every third cycle thereafter. Standard evaluation included two-dimensional measurement of evaluable disease. Standard criteria for response were used. Therapy was discontinued if progression occurred after at least two cycles of therapy. Quality of life and symptoms were assessed.


RESULTS
Forty-one patients were enrolled. Ninety-two percent of patients had >2 previous chemotherapy regimens. All patients had platinum- and taxane-resistant disease. Thirty-six patients were evaluable for response. Three patients had a partial response, with a median response duration of five cycles. Twenty-two patients had stable disease for 3 to 11 cycles (median, 6 cycles). Eleven had progressive disease. The only grade 4 toxicity was abdominal pain (n = 2). The most common grade 3 toxicities were fatigue (n = 19), hand-foot syndrome (n = 11), abdominal pain (n = 7), and diarrhea (n = 4). One patient had a grade 3 hematologic toxicity (anemia).


CONCLUSIONS
Capecitabine at the dosages used in this study is well tolerated and has minimal hematologic toxicity.
Wolf
Judith K
JK
Department of Gynecologic Oncology, Unit 1362, The University of Texas M. D. Anderson Cancer Center, 1155 Herman Pressler, Houston, TX 77030, USA. jwolf@mdanderson.org
Bodurka
Diane C
DC
Verschraegen
Claire
C
Sun
Charlotte C
CC
Branham
Donna
D
Jenkins
Alfred D
AD
Atkinson
Neely
N
Gershenson
David M
DM
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D001952:Bridged-Ring Compounds / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019008:Drug Resistance, Neoplasm; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010534:Peritoneal Neoplasms / Q000188:drug therapy*; D017671:Platinum Compounds / Q000627:therapeutic use*; D043823:Taxoids / Q000627:therapeutic use*
D000964:Antimetabolites, Antineoplastic; D001952:Bridged-Ring Compounds; D017671:Platinum Compounds; D043823:Taxoids; D003841:Deoxycytidine; C080625:taxane; D000069287:Capecitabine; D005472:Fluorouracil