S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma
Condition: Extrahepatic Bile Duct Cancer; Gallbladder Cancer
MeSH terms: Cholangiocarcinoma; Gallbladder Neoplasms; Bile Duct Neoplasms
Intervention: capecitabine; gemcitabine hydrochloride
Intervention description: 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1,8, every 21 days
Intervention MeSH terms: Gemcitabine; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: unresectable gallbladder cancer; recurrent gallbladder cancer; unresectable extrahepatic bile duct cancer; recurrent extrahepatic bile duct cancer; adenocarcinoma of the gallbladder; adenocarcinoma with squamous metaplasia of the gallbladder; squamous cell carcinoma of the gallbladder; adenocarcinoma of the extrahepatic bile duct; cholangiocarcinoma of the gallbladder; cholangiocarcinoma of the extrahepatic bile duct

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, use different
      ways to stop tumor cells from dividing so they stop growing or die. Combining more than one
      drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine
      in treating patients who have locally advanced or metastatic gallbladder cancer or
      cholangiocarcinoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed gallbladder cancer or cholangiocarcinoma

               -  Locally advanced or metastatic disease that is unresectable

               -  Eligible subtypes:

                    -  Adenocarcinoma, intestinal type

                    -  Adenocarcinoma, not otherwise specified (NOS)

                    -  Papillary carcinoma

                    -  Clear cell adenocarcinoma

                    -  Mucinous carcinoma

                    -  Signet ring cell carcinoma

                    -  Squamous cell carcinoma

                    -  Adenosquamous carcinoma

                    -  Small cell carcinoma

                    -  Undifferentiated carcinoma

                    -  Carcinoma, NOS

        OR

          -  Histologically confirmed adenocarcinoma of a metastatic site with clinical
             documentation* of gallbladder or bile duct involvement and no evidence of another
             primary

        NOTE: *If clinical documentation of gallbladder or bile duct involvement is not possible
        due to removal of the organ, a clinically and/or radiographically consistent picture plus
        pathologic findings from the metastatic site consistent with cholangiocarcinoma are allowed

          -  Measurable disease located outside prior radiotherapy port

          -  No carcinoid tumors or sarcomas

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Zubrod 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Absolute granulocyte count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic:

          -  Bilirubin no greater than 3 times upper limit of normal (ULN)

          -  Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase
             (SGPT) no greater than 2.5 times ULN (5 times ULN if liver metastasis is present)

        Renal:

          -  Creatinine clearance at least 30 mL/min

        Cardiovascular:

          -  No clinically significant cardiac disease that is not well controlled by medication

          -  No congestive heart failure

          -  No symptomatic coronary artery disease

          -  No cardiac arrhythmias

          -  No myocardial infarction within the past 12 months

        Gastrointestinal:

          -  Able to swallow and/or receive medications via gastrostomy feeding tube

          -  No intractable nausea or vomiting

          -  No malabsorption syndrome

        Other:

          -  No severe reaction to fluoropyrimidine therapy or known hypersensitivity to
             fluorouracil

          -  No other malignancy within the past 5 years except:

               -  Adequately treated basal cell or squamous cell skin cancer

               -  Carcinoma in situ of the cervix

               -  Adequately treated stage I or II cancer currently in complete remission

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Prior neoadjuvant or adjuvant immunotherapy allowed provided therapy was completed at
             least 1 year before documented recurrence or metastatic disease

          -  No concurrent immunotherapy

        Chemotherapy:

          -  Prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy allowed provided
             therapy was completed at least 1 year before documented recurrence or metastatic
             disease

          -  No other concurrent chemotherapy

        Endocrine therapy:

          -  Prior neoadjuvant or adjuvant hormonal therapy allowed provided therapy was completed
             at least 1 year before documented recurrence or metastatic disease

          -  No concurrent hormonal therapy

        Radiotherapy:

          -  See Disease Characteristics

          -  See Chemotherapy

          -  Recovered from prior radiotherapy

          -  Prior neoadjuvant or adjuvant radiotherapy allowed provided therapy was completed at
             least 1 year before documented recurrence or metastatic disease

          -  No prior radiotherapy to 25% or more of bone marrow

          -  No concurrent radiotherapy except for palliation of metastatic sites not considered
             target lesions

        Surgery:

          -  At least 2 weeks since prior surgery for this malignancy and recovered

        Other:

          -  No prior treatment for metastatic disease

          -  No other concurrent therapy for this cancer