A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer

• Status: Terminated
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Study Hypothesis: To estimate time to recurrence in pancreatic cancer patients treated with adjuvant erlotinib and gemcitabine. Combination therapy will be given for 4 months followed by single agent erlotinib for a total of 12 months.

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

Details

• Lead Sponsor: Herbert J. Zeh, III MD, FACS
• Collaborator: Genentech, Inc.
• Treatments: Erlotinib Hydrochloride; Gemcitabine

Criteria

Inclusion Criteria:

• Patients with potentially resectable pancreatic cancer (including ampullary cancer), prior to or after surgery will be accrued to this study.

• Patients who sign consent prior to surgery must have appropriate diagnostic imaging and be evaluated by one of the surgical co-investigators as having resectable disease, and probable pancreatic adenocarcinoma.

• Patients, who sign consent after surgery, must have adenocarcinoma of the pancreas with negative surgical margins.

• Adjuvant therapy should start within 10 weeks of surgery

• Age 18 years or older

• ECOG performance status of 0 - 1 (see Appendix A)

• Ability to take oral medications without difficulty

• Adequate bone marrow function as evidenced by an absolute neutrophil content (ANC) > 1500/mL and platelet count > 100,000/mL

• Adequate renal function as evidenced by serum creatinine within institutional limits or creatinine clearance > 50 ml/minute if above upper institutional limits (ULN)

• Adequate hepatic function as evidenced by ALT and total bilirubin within 2 times ULN.

• Provision of written informed consent.

• Men and women of childbearing potential must be willing to practice acceptable methods of birth control to prevent pregnancy.

Exclusion Criteria:

• Positive margins on post operative surgical specimen or evidence of metastatic disease (positive retroperitoneal margin is allowed)

• Biliary tree cancers are not allowed (Note: Ampullary cancer allowed).

• Known severe hypersensitivity to erlotinib or any of the excipients of these products

• Any prior treatment with radiation therapy or chemotherapy or vaccines for pancreatic cancer.

• Other coexisting malignancies or malignancies diagnosed within the last 3 years, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin or cervical cancer in situ.

• Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's Wort. Other agents which inhibit CYP3A4 may be used with caution (Appendix B)

• Treatment with a non-approved or investigational drug prior to treatment.

• Incomplete healing from previous oncologic or other major surgery.

• Pregnancy or breast feeding (women of childbearing potential).

• As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).

• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.