Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

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

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.

Detailed description: PATIENT POPULATION Resected pancreatic cancer patients (R0 resection) within 10 weeks of surgery will be eligible, provided that they meet standard eligibility criteria.
  STUDY DESIGN Phase II, open-label trial of erlotinib and gemcitabine. SAFETY PLAN Safety as assessed by CTCAE 3.0 STUDY TREATMENT Erlotinib 150 mg/day x 12 months. (oral) Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months Patients will be monitored with serial CT scans for the first 2 years after completion of therapy.
  Clinical Practice: Therapy will be administered as an outpatient. Primary Evaluations: Time to recurrence CONCOMITANT THERAPY AND CLINICAL PRACTICE No other anti-cancer therapy will be allowed while on study.

Eligibility: 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.

Relevance to patient case: not relevant