Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of Gallbladder Cancer

Inclusion Criteria:

• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Patient must have histologically-confirmed T2 or T3 gallbladder cancer discoveredincidentally at the time of or following routine cholecystectomy for presumed benigndisease

• NOTE: Patients with histologically-confirmed Tis, T1a, T1b, or T4 tumors arenot eligible

• Patient must have undergone initial cholecystectomy within 12 weeks prior torandomization

• Patient must have the ability to understand and the willingness to sign a writteninformed consent document

• Leukocytes >= 3,000/mcL (obtained =< 28 days prior to randomization)

• Absolute neutrophil count >= 1,500/mcL (obtained =< 28 days prior to randomization)

• Platelets >= 100,000/mcL (obtained =< 28 days prior to randomization)

• Total bilirubin =< institutional upper limit of normal (ULN) except in patients withGilbert's syndrome. Patients with Gilbert's syndrome are eligible if directbilirubin < 1.5 x ULN of the direct bilirubin (obtained =< 28 days prior torandomization)

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 28 days prior to randomization)

• Serum creatinine =< institutional ULN OR creatinine clearance >= 50 mL/min/1.73 m^2 (Based on Cockcroft Gault estimation) (obtained =< 28 days prior to randomization)

• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviraltherapy with undetectable viral load within 6 months of randomization are eligiblefor this trial

• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBVviral load must be undetectable on suppressive therapy, if indicated

• Patients with a history of hepatitis C virus (HCV) infection must have been treatedand cured. For patients with HCV infection who are currently on treatment, they areeligible if they have an undetectable HCV viral load

• Patients with a prior or concurrent malignancy whose natural history or treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen are eligible for this trial

• Patients with known history or current symptoms of cardiac disease, or history oftreatment with cardiotoxic agents, should have a clinical risk assessment of cardiacfunction using the New York Heart Association functional classification. To beeligible for this trial, patients should be class 2B or better

Exclusion Criteria:

• Patient must not have any evidence of metastatic disease or inoperable loco-regionaldisease based on high-quality, preoperative, cross-sectional imaging (computedtomography [CT] or magnetic resonance imaging [MRI]) of the chest, abdomen, andpelvis (C/A/P) obtained within 6 weeks prior to randomization, defined as

• No radiographic evidence of distant disease (M1 disease)

• No radiographic evidence of tumor invasion into multiple extrahepatic organs (T4 disease)

• No radiographic evidence of distant lymph node involvement (celiac,para-aortic, para-caval lymph nodes)

• No evidence of new-onset ascites

• Soft tissue thickening within or in direct communication with the gallbladderfossa, peri-portal lymph node involvement, involvement of one extrahepaticorgan, and other disease within the confines of what constitutes 'localizedresectable' disease are allowable

• Women must not be pregnant or breast feeding due to the potential harm to unbornfetus and possible risk for adverse events in nursing infants with the treatmentregimens being used. All females of child bearing potential must have a serum orurine pregnancy test to rule out pregnancy within 14 days prior to randomization. Afemale of childbearing potential is defined as any woman, regardless of sexualorientation or whether they have undergone tubal ligation, who meets the followingcriteria: 1) has achieved menarche at some point, 2) has not undergone ahysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) forat least 24 consecutive months (i.e., has had menses at any time in the preceding 24consecutive months)

• Women of childbearing potential and sexually active males must not expect toconceive or father children by being strongly advised to use accepted and effectivemethod(s) of contraception or to abstain from sexual intercourse for the duration oftheir participation in the study