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

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

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

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.

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

- 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

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to recurrence

Outcome Time Frame:

1-2 years

Safety Issue:


Principal Investigator

Herb Zeh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

November 2011

Related Keywords:

  • Pancreatic Cancer
  • Pancreas
  • Cancer
  • Pancreatic
  • Pancreatic Neoplasms



UPMC Cancer Centers NetworkPittsburgh, Pennsylvania  15232