Sorafenib and Erlotinib in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib works in treating patients with pancreatic cancer that cannot be removed by surgery.

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

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride; Niacinamide; Sorafenib

Criteria

DISEASE CHARACTERISTICS:

• Microscopically confirmed diagnosis of pancreatic adenocarcinoma

• Unresectable disease

• No neuroendocrine tumors or cystadenocarcinoma

• Measurable or evaluable disease by RECIST criteria

• No known brain metastases

• Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• ANC ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)

• Creatinine ≤ 1.5 times ULN

• INR < 1.5 or PT/PTT normal unless patients are receiving anticoagulation treatments

• Negative pregnancy test

• Not pregnant or nursing

• Fertile patients must use effective barrier contraception before, during, and for at least 6 months after completion of study treatment

• Able to swallow whole pills

• No patients who currently smoke

• No cardiac disease, including any of the following:

• NYHA class III-IV congestive heart failure

• Unstable angina (anginal symptoms at rest)

• New-onset angina (began within the past 3 months)

• Myocardial infarction within the past 6 months

• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

• No uncontrolled hypertension defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg despite optimal medical management

• No arterial thrombotic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months

• No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 in the past 4 weeks

• No other hemorrhage/bleeding event ≥ CTCAE grade 3 in the past 4 weeks

• No significant traumatic injury in the past 4 weeks

• No known untreated malabsorption problem (e.g., ulcerative colitis, Crohn's disease)

• No known HIV positivity or chronic hepatitis B or C

• No known or suspected allergy to sorafenib tosylate or erlotinib hydrochloride

• No active clinically serious infection > CTCAE grade 2

• No serious non-healing wound, ulcer, or bone fracture

• No evidence or history of bleeding diathesis or coagulopathy (except for cancer-related blood clots)

• No dermatitis ≥ CTCAE grade 2 at baseline

• No patients who currently smoke

PRIOR CONCURRENT THERAPY:

• No prior treatment with antiangiogenics (e.g., bevacizumab, thalidomide, marimastat, interferon alfa, vatalanib, vandetanib, ZD6126, sorafenib, semaxanib, sunitinib, axitinib)

• No more than one line of prior therapy for metastatic disease

• More than 4 weeks since prior major surgery or open biopsy

• No concurrent strong CYP34A inhibitors or inducers

• Concurrent warfarin or heparin allowed with the approval of the principal investigator