TY - JOUR
T1 - A Phase II trial of oral capecitabine in patients with platinum - and taxane - refractory ovarian, fallopian tube, or peritoneal cancer
AU - Wolf, Judith K.
AU - Bodurka, Diane C.
AU - Verschraegen, Claire
AU - Sun, Charlotte C.
AU - Branham, Donna
AU - Jenkins, Alfred D.
AU - Atkinson, Neely
AU - Gershenson, David M.
PY - 2006/9
Y1 - 2006/9
N2 - Purpose: To determine the efficacy, toxicity, and quality of life of capecitabine (Xeloda), an oral 5-fluorouracil derivative, in patients with chemorefractory recurrent mullerian cancers. Patients and 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). Conclusion: Capecitabine at the dosages used in this study is well tolerated and has minimal hematologic toxicity.
AB - Purpose: To determine the efficacy, toxicity, and quality of life of capecitabine (Xeloda), an oral 5-fluorouracil derivative, in patients with chemorefractory recurrent mullerian cancers. Patients and 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). Conclusion: Capecitabine at the dosages used in this study is well tolerated and has minimal hematologic toxicity.
KW - Capecitabine
KW - Ovarian cancer
KW - Phase II clinical trial
KW - Recurrence
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U2 - 10.1016/j.ygyno.2005.12.040
DO - 10.1016/j.ygyno.2005.12.040
M3 - Article
C2 - 16516276
AN - SCOPUS:33748442448
SN - 0090-8258
VL - 102
SP - 468
EP - 474
JO - Gynecologic oncology
JF - Gynecologic oncology
IS - 3
ER -