PURPOSE: To define dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of capecitabine with fixed-dose rate (FDR) gemcitabine. METHODS: Eligible adults (advanced solid tumor; performance status <or=2) received capecitabine 500 mg/m(2) PO BID days 1-14 and FDR gemcitabine (400-1,000 mg/m(2) escalated by 200 mg/m(2) increments) at 10 mg/m(2)/min days 1 and 8 on a 21-day cycle. A traditional 3 + 3 cohort design was used to determine the MTD. RESULTS: Thirty patients (median age 59 years) were enrolled. The predominant grade >or=3 toxicity was myelosuppression, particularly neutropenia. At dose level 4 (1,000 mg/m(2) gemcitabine), two out of five evaluable patients had a DLT (grade 4 neutropenia >or=7 days). At dose level 3 (800 mg/m(2) gemcitabine), one patient had a DLT (grade 3 neutropenia >or=7 days) among six evaluable patients. Therefore, the MTD and recommended phase II dose was designated as capecitabine 500 mg/m(2) PO BID days 1-14 with 800 mg/m(2) FDR gemcitabine days 1 and 8 infused at 10 mg/m(2) per min on a 21-day cycle. Partial responses occurred in pretreated patients with esophageal, renal cell and bladder carcinomas. CONCLUSIONS: This regimen was well tolerated and may deserve evaluation in advanced gastrointestinal and genitourinary carcinomas.
PURPOSE: To define dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of capecitabine with fixed-dose rate (FDR) gemcitabine. METHODS: Eligible adults (advanced solid tumor; performance status <or=2) received capecitabine 500 mg/m(2) PO BID days 1-14 and FDR gemcitabine (400-1,000 mg/m(2) escalated by 200 mg/m(2) increments) at 10 mg/m(2)/min days 1 and 8 on a 21-day cycle. A traditional 3 + 3 cohort design was used to determine the MTD. RESULTS: Thirty patients (median age 59 years) were enrolled. The predominant grade >or=3 toxicity was myelosuppression, particularly neutropenia. At dose level 4 (1,000 mg/m(2) gemcitabine), two out of five evaluable patients had a DLT (grade 4 neutropenia >or=7 days). At dose level 3 (800 mg/m(2) gemcitabine), one patient had a DLT (grade 3 neutropenia >or=7 days) among six evaluable patients. Therefore, the MTD and recommended phase II dose was designated as capecitabine 500 mg/m(2) PO BID days 1-14 with 800 mg/m(2) FDR gemcitabine days 1 and 8 infused at 10 mg/m(2) per min on a 21-day cycle. Partial responses occurred in pretreated patients with esophageal, renal cell and bladder carcinomas. CONCLUSIONS: This regimen was well tolerated and may deserve evaluation in advanced gastrointestinal and genitourinary carcinomas.
Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506
Authors: Richard L Schilsky; Donna Bertucci; Nicholas J Vogelzang; Hedy L Kindler; Mark J Ratain Journal: J Clin Oncol Date: 2002-01-15 Impact factor: 44.544
Authors: Margaret Tempero; William Plunkett; Veronique Ruiz Van Haperen; John Hainsworth; Howard Hochster; Renato Lenzi; James Abbruzzese Journal: J Clin Oncol Date: 2003-07-28 Impact factor: 44.544
Authors: Viviane Hess; Marc Salzberg; Markus Borner; Rudolf Morant; Arnaud D Roth; Christian Ludwig; Richard Herrmann Journal: J Clin Oncol Date: 2003-01-01 Impact factor: 44.544
Authors: J L Abbruzzese; R Grunewald; E A Weeks; D Gravel; T Adams; B Nowak; S Mineishi; P Tarassoff; W Satterlee; M N Raber Journal: J Clin Oncol Date: 1991-03 Impact factor: 44.544
Authors: Min-Young Lee; Ki Sun Jung; Hae Su Kim; Ji Yun Lee; Sung Hee Lim; Moonjin Kim; Hyun Ae Jung; Sung Min Kim; Jong Mu Sun; Myung-Ju Ahn; Jeeyun Lee; Se Hoon Park; Seong Yoon Yi; In Gyu Hwang; Sang-Cheol Lee; Hee Kyung Ahn; Do Hyoung Lim; Soon Il Lee; Keon Woo Park Journal: World J Gastroenterol Date: 2015-04-14 Impact factor: 5.742