A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients with Unresectable or Metastatic Gallbladder or Cholangiocarcinoma

Cytologically or pathologically confirmed gallbladder or cholangiocarcinoma. Pathologic confirmation may be made from primary or metastatic site. Patients with pathologic confirmation of adenocarcinoma of a metastatic site, along with clinical documentation of gallbladder or bile duct involvement and no evidence of another primary are also eligible. If clinical documentation of gallbladder or bile duct involvement is not possible because of removal of the organ, a clinically and/or radiographically consistent picture plus pathologic findings from the metastatic site that are determined to be consistent with cholangiocarcinoma are acceptable. Must have locally advanced or distant metastatic disease that is not surgically curable. Must have measurable disease. Prior surgery for gallbladder or cholangiocarcinoma is allowed as long as at least 14 days prior to registration and recovered from all effects. No prior treatment for metastatic disease. Prior chemotherapy, hormonal therapy, immunotherapy, radiation therapy (to less than 25% of bone marrow only), and chemotherapy as neoadjuvant or adjuvant treatment is allowed as long as completed at least 12 months prior to documented recurrence or metastatic disease. Measurable disease must be outside of the RT port and must have recovered from all RT effects. Adequate bone marrow reserve, renal and hepatic function. Zubrod performance status 0-2. Must not have reaction to fluoropyrimidine or known hypersensitivity to 5-FU. Must either be able to swallow and/or receive enteral medications via gastrostomy feeding tube. Must not have intractable nausea, vomiting or malabsorption syndrome. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in remission or any other cancer from which the patient has been disease-free for 5 years.