A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Gemcitabine; Erlotinib
Intervention description: 1500mg/m2 IV over 150 min IV q 2 weeks 4 months; 150 mg/d Daily, oral 12 months
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreas; Cancer; Pancreatic

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.
    

Eligibility 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.