A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
- 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.
- 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
- 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
- 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
- Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the subject to participate in the trial.