Status:
TERMINATED
Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients ...
Detailed Description
OBJECTIVES: Primary * Determine the progression-free survival (PFS) of patients with stage III or IV adenocarcinoma of the pancreas treated with erlotinib hydrochloride as first- or second-line ther...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Locally advanced inoperable or metastatic disease (stage III or IV disease)
- No more than 1 prior systemic therapy
- Patients who have not received 1 prior systemic therapy must meet 1 of the following criteria:
- Ineligible for or refused chemoradiotherapy AND has stage III disease
- Ineligible for or refused gemcitabine hydrochloride-based chemotherapy AND has stage IV disease
- No brain metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 3 months
- WBC \> 3,000/mm³
- ANC \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Bilirubin ≤ 2 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in patients with documented liver metastases)
- Creatinine \< 1.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- No uncontrolled comorbid illness that is likely to increase toxicity of the study drug or to interfere with toxicity evaluation
- No known allergy to the study drug or its excipients
- No symptomatic interstitial pulmonary disease
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior adjuvant therapy allowed provided it was completed at least 28 days prior to study entry
- No prior EGFR-inhibitor
- No concurrent drugs that are known to be strong inducers or inhibitors of the CYP450 enzyme system
- No concurrent Hypericum perforatum (St. John's wort)
- No concurrent investigational or commercial agents or therapies with the intent to treat the patient's malignancy
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00470535
Start Date
January 1 2007
End Date
September 1 2010
Last Update
February 23 2017
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001