Status:
COMPLETED
Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors
Lead Sponsor:
University College, London
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief 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. Givin...
Detailed Description
OBJECTIVES: Primary * Compare the overall survival of patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with gemcitabine hydrochlorid...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT00262769
Start Date
May 1 2005
Last Update
July 17 2012
Active Locations (25)
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1
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
2
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
3
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
4
Cumberland Infirmary
Carlisle, England, United Kingdom, CA2 7HY