Status:
COMPLETED
Oxaliplatin, Gemcitabine, Erlotinib, and Radiation Therapy in Treating Patients With Unresectable and/or Metastatic Pancreatic Cancer or Biliary Tract Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erl...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose (MTD) of oxaliplatin and gemcitabine hydrochloride when combined with radiotherapy in patients with unresectable and/or metastatic pancreatic or bil...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Biopsy confirmed diagnosis of any of the following:
- Pancreatic carcinoma
- Ampullary carcinoma
- Biliary tract (gallbladder or bile duct) carcinoma
- Unresectable and/or biopsy-proven metastatic disease
- Suitable for bimodality therapy, as determined by a medical oncologist and radiation oncologist
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 2 months
- ANC \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Creatinine \< 1.5 mg/dL
- Total bilirubin \< 2 times upper limit of normal (ULN)
- AST \< 3 times ULN (\< 5 times ULN if liver metastases are present)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known hypersensitivity to platinum agent or gemcitabine hydrochloride
- No serious medical or psychiatric illnesses that would preclude giving informed consent
- PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the upper abdomen
- More than 3 weeks since prior chemotherapy
- No prior erlotinib hydrochloride
- At least 5 days since prior and no concurrent CYP3A4 inducer/inhibitor
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00266097
Start Date
August 1 2004
End Date
September 1 2011
Last Update
March 7 2012
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295