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

Inclusion 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