Oxaliplatin/Capecitabine Active in Unresectable Cholangiocarcinoma

August 1, 2005

HOUSTON, TEXAS-Preliminarydata from a phase II study ofoxaliplatin (Eloxatin) and capecitabine(Xeloda) in patients with unresectablegallbladder and biliary tract cancersshow a response rate of 18% in

HOUSTON, TEXAS-Preliminarydata from a phase II study ofoxaliplatin (Eloxatin) and capecitabine(Xeloda) in patients with unresectablegallbladder and biliary tract cancersshow a response rate of 18% inpreviously untreated patients (abstract4123). "This [study] provides proof ofactivity in this disease and shows thatthis regimen should be tested further,"Katrina Y. Glover, MD, told OncologyNews International.Although malignancies of the gallbladderand biliary tract are uncommonin the United States, Dr. Glover,of UT-M. D. Anderson Cancer Cen-ter, pointed out that they are commonin certain Japanese, Chilean, andNative American populations. "Mostpatients present with advanced diseaseand are not candidates for potentiallycurative resection. Response ratesrange from 10% to 20% for patientsreceiving palliative chemotherapy, indicatingthe need for new therapeuticregimens," Dr. Glover said.

Trial Is OngoingThis ongoing trial is a prospectivestudy of capecitabine (750 mg/m2 twicedaily on days 1-14) in combinationwith oxaliplatin (originally dosed at130 mg/m2 on day 1 every 21 days;XELOX). The starting dose of oxaliplatinwas reduced to 100 mg/m2 afterprolonged myelosuppression, fatigue,and decreased performance status wereobserved at the higher dose in the first12 patients treated.The trial is enrolling patients withunresectable or recurrent cholangiocarcinoma.The preliminary report includedthe 30 patients enrolled to date,of whom 97% had adenocarcinomaand 3% had squamous carcinoma.Patients are being stratified accordingto whether they received prior chemotherapy(7 patients) vs no priorchemotherapy (23 patients). Studyendpoints are response rate (RR), safety,and survival. At the time of thisreport, 28 patients were evaluable forboth response and toxicity.Dr. Glover reported that the overallRR was 18% and that response rateswere 19% in patients who had undergoneprior chemotherapy and 14% inpreviously untreated patients (Table1). 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 werecommon. Grade 3 fatigue and diarrheaoccurred in 27% and 18% ofpatients respectively.Response Consistent WithThat of Other Agents"The overall response rate of 18%observed with XELOX appears to beconsistent with the response rates ofother palliative chemotherapy agentsused in biliary tract cancers. While notsuperior to other palliative chemotherapyregimens, XELOX should beconsidered an active regimen in thetreatment of unresectable gallbladdercancer and cholangiocarcinoma, especiallyin previously untreated patients.With careful attention to dose,XELOX is well tolerated with mini-Findings are called significant and unprecedentedmal toxicity," Dr. Glover said. Accrualin this trial will continue to a total of50 patients.