Clinical trial NCT00262769 (phase 3, status: completed)
Conditions: extrahepatic bile duct cancer, gallbladder cancer
ICD codes: C24.0, D13.5, C23, D37.6
Drugs: cisplatin, gemcitabine hydrochloride
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed biliary tract, gallbladder, or ampullary
             carcinoma

               -  Intra- or extra-hepatic disease allowed

          -  Unresectable locally advanced, recurrent, or metastatic disease

          -  No brain metastases

        PATIENT CHARACTERISTICS:

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  At least 3 months

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 10 g/dL (transfusion allowed)

          -  WBC ≥ 3,000/mm^3

        Hepatic

          -  AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are
             present)

          -  Bilirubin ≤ 1.5 times ULN

          -  Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present)

          -  Adequate biliary drainage

          -  No unresolved biliary tract obstruction

        Renal

          -  Creatinine < 1.5 times ULN

          -  Urea < 1.5 times ULN

          -  Glomerular filtration rate (GFR) ≥ 45 mL/min

               -  If GFR < 60 mL/min, isotope EDTA confirmation of adequate renal function is
                  required

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after study
             participation

          -  No active, uncontrolled infection

          -  No other severe or uncontrolled systemic disease

          -  No other malignancy within the past 5 years except nonmetastatic basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix treated by cone-biopsy or
             resection

          -  No psychiatric disorder that would preclude giving informed consent

        PRIOR CONCURRENT THERAPY:

        Chemotherapy

          -  At least 6 months since prior adjuvant chemotherapy

          -  No prior gemcitabine hydrochloride

          -  No prior cisplatin

          -  No prior systemic chemotherapy for locally advanced or metastatic disease except
             low-dose radiosensitizing chemotherapy in conjunction with radiotherapy

        Radiotherapy

          -  Prior radiotherapy for localized disease allowed provided there is clear evidence of
             disease progression afterwards

        Surgery

          -  Prior curative surgery allowed provided there is evidence of nonresectable disease
             relapse requiring systemic chemotherapy

        Other

          -  Recovered from all prior therapies

          -  Prior photodynamic therapy (PDT) allowed provided it was given for localized disease
             only (with no evidence of metastatic disease) and resulted in subsequent disease
             progression after completion of therapy OR to relieve biliary obstruction in the
             presence of metastatic disease

               -  PDT must have been completed ≥ 4 weeks ago

          -  At least 4 weeks since prior investigational agents

          -  No other concurrent, curative anticancer therapy