Status:
COMPLETED
Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer
Lead Sponsor:
Centre Antoine Lacassagne
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Er...
Detailed Description
OBJECTIVES: Primary * Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride, capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer. Se...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Advanced disease
- No standard curative therapy available
- Must have received prior first-line chemotherapy
- No brain metastasis
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy ≥ 8 weeks
- ANC ≥ 1.5 x 10\^9/ L
- Platelet count ≥ 130 x 10\^9/ L
- Hemoglobin ≥ 10 g/dL
- Liver transaminases ≤ 1.5 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)
- Bilirubin ≤ 1.5 times ULN
- Creatinine ≤ 130 mmol/L OR creatinine clearance \> 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No intolerance or hypersensitivity to any of the drugs being tested
- No history of interstitial lung disease
- No history of severe cardiac disease
- No serious uncontrolled infection
- No rare hereditary disorders, i.e., galactosemia, lactase deficiency, or malabsorption of glucose or galactose syndrome
- Must not be deprived of liberty or under guardianship
- Must not be on probation
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior erlotinib hydrochloride
- No concurrent potent inducers or inhibitors of cytochrome P450 or CYP3A4
- More than 14 days since participation in another clinical trial
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00885066
Start Date
May 1 2008
End Date
October 1 2009
Last Update
September 30 2025
Active Locations (1)
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1
Centre Antoine Lacassagne
Nice, France, 06189