Gemcitabine, Alone or in Combination With Cisplatin, in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumors: A Multicentre, Randomized Phase III Study
16 Years
N/A
Both
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
Trial Information
Gemcitabine, Alone or in Combination With Cisplatin, in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumors: A Multicentre, Randomized Phase III Study
OBJECTIVES:
Primary
- Compare the overall survival of patients with unresectable locally advanced or
metastatic cholangiocarcinoma or other biliary tract tumors treated with gemcitabine
hydrochloride with vs without cisplatin.
Secondary
- Compare the progression-free survival of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, primary site of disease (gallbladder vs bile ducts vs ampulla), prior
therapy (photodynamic therapy [PDT] vs non-PDT therapy vs none), ECOG performance status (0
vs 1 vs 2), and disease status (locally advanced vs metastatic). Patients are randomized to
1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and
15. Treatment repeats every 28 days for 6 courses in the absence of disease progression
or unacceptable toxicity.
- Arm II: Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV
over 1½ hours on days 1 and 8. Treatment repeats every 21 days for 8 courses in the
absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 12 weeks, and after finishing treatment.
After completion of study treatment, patients are followed periodically for at least 3
years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Description:
From date of randomisation till date of death or last date of follow-up (up to 5 years)
Outcome Time Frame:
From date of randomisation till date of death or last date of follow-up (up to 5 years)
Safety Issue:
No
Principal Investigator
John A. Bridgewater
Investigator Role:
Study Chair
Investigator Affiliation:
University College London (UCL) Cancer Institute
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
CDR0000455013
NCT ID:
NCT00262769
Start Date:
May 2005
Completion Date:
Related Keywords:
- Extrahepatic Bile Duct Cancer
- Gallbladder Cancer
- cholangiocarcinoma of the extrahepatic bile duct
- recurrent extrahepatic bile duct cancer
- unresectable extrahepatic bile duct cancer
- cholangiocarcinoma of the gallbladder
- recurrent gallbladder cancer
- unresectable gallbladder cancer
- metastatic extrahepatic bile duct cancer
- metastatic gallbladder cancer
- Gallbladder Neoplasms
- Bile Duct Neoplasms
- Cholangiocarcinoma
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