Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without cisplatin in treating cholangiocarcinoma or biliary tract tumors.

PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine alone in treating patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Collaborator: Eli Lilly and Company
• Treatments: Cisplatin; Gemcitabine

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