Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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 with stage III or stage IV pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Treatments: Erlotinib Hydrochloride

Criteria

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