DETROITA phase II trial of capecitabine (Xeloda) plus oxaliplatin (Eloxatin,
investigational in the United States) supports European data suggesting that
the combination is active in advanced colorectal cancer, and with manageable
Anthony Shields, MD, PhD, professor of medicine and oncology, Barbara Ann
Karmanos Cancer Institute, Detroit, reported the results at the 38th Annual
Meeting of the American Society of Clinical Oncology (abstract 568).
The investigators planned a two-stage trial with an accrual goal of 35
patients if at least 3 of the first 17 patients responded. After treating 13
patients, however, they opted to make a toxicity-related dose reduction in
the capecitabine. An additional 35 patients were entered into the study and
treated at the lower dose, for a total of 48 treated patients overall.
The median age of the patients was 60. Twenty-eight had colon cancer, and
20 rectal cancer; 18 had received adjuvant chemotherapy. Most (45) were ECOG
performance status 0-1.
The initial 13 patients received capecitabine 1,000 mg/m² bid on days 1
to 14 of a 21-day cycle and 130 mg/m² of oxaliplatin by infusion on day 1.
"We found that we couldn’t deliver the 2,000 mg/m² dose of
capecitabine because of toxicity," he said. "So we cut the dose
down to 1,500 mg/m² per day [750 mg/m² bid]."
Five (38.4%) of the 13 patients given the higher starting dose responded.
Within the first two cycles, however, six patients were hospitalized for
toxicityfive with diarrhea and dehydration. Six of these 13 patients have
now experienced disease progression.
Of the patients who received the lower dose, 14 of 35 (40%) had a par-tial
response. The median estimated progression-free survival was 6.9 months
(range, 4.4 to 8.9). Sixteen patients have progressed, and one has died.