HOUSTON, TEXAS-Preliminary data from a phase II study of oxaliplatin(Drug information on oxaliplatin) (Eloxatin) and capecitabine(Drug information on capecitabine) (Xeloda) in patients with unresectable gallbladder and biliary tract cancers show a response rate of 18% in previously untreated patients (abstract 4123). "This [study] provides proof of activity in this disease and shows that this regimen should be tested further," Katrina Y. Glover, MD, told Oncology News International. Although malignancies of the gallbladder and biliary tract are uncommon in the United States, Dr. Glover, of UT-M. D. Anderson Cancer Cen- ter, pointed out that they are common in certain Japanese, Chilean, and Native American populations. "Most patients present with advanced disease and are not candidates for potentially curative resection. Response rates range from 10% to 20% for patients receiving palliative chemotherapy, indicating the need for new therapeutic regimens," Dr. Glover said. Trial Is Ongoing This ongoing trial is a prospective study of capecitabine (750 mg/m2 twice daily on days 1-14) in combination with oxaliplatin (originally dosed at 130 mg/m2 on day 1 every 21 days; XELOX). The starting dose of oxaliplatin was reduced to 100 mg/m2 after prolonged myelosuppression, fatigue, and decreased performance status were observed at the higher dose in the first 12 patients treated. The trial is enrolling patients with unresectable or recurrent cholangiocarcinoma. The preliminary report included the 30 patients enrolled to date, of whom 97% had adenocarcinoma and 3% had squamous carcinoma. Patients are being stratified according to whether they received prior chemotherapy (7 patients) vs no prior chemotherapy (23 patients). Study endpoints are response rate (RR), safety, and survival. At the time of this report, 28 patients were evaluable for both response and toxicity. Dr. Glover reported that the overall RR was 18% and that response rates were 19% in patients who had undergone prior chemotherapy and 14% in previously untreated patients (Table 1). Following three courses of therapy, 34% of patients had stable disease, and 43% had disease progression. Dr. Glover said that grade 1 neurotoxicity, diarrhea, anorexia, and nausea were common. Grade 3 fatigue and diarrhea occurred in 27% and 18% of patients respectively. Response Consistent With That of Other Agents "The overall response rate of 18% observed with XELOX appears to be consistent with the response rates of other palliative chemotherapy agents used in biliary tract cancers. While not superior to other palliative chemotherapy regimens, XELOX should be considered an active regimen in the treatment of unresectable gallbladder cancer and cholangiocarcinoma, especially in previously untreated patients. With careful attention to dose, XELOX is well tolerated with mini- Findings are called significant and unprecedented mal toxicity," Dr. Glover said. Accrual in this trial will continue to a total of 50 patients.