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

NCT ID: NCT00336700

Last Updated: 2016-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2011-11-30

Brief 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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine and Erlotinib

Erlotinib (oral) 150 mg/day x 12 months Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

1500mg/m2 IV over 150 min IV q 2 weeks 4 months

Erlotinib

Intervention Type: DRUG

150 mg/d Daily, oral 12 months

Interventions

Gemcitabine

1500mg/m2 IV over 150 min IV q 2 weeks 4 months

Intervention Type: DRUG

Erlotinib

150 mg/d Daily, oral 12 months

Intervention Type: DRUG

Other Intervention Names

Gemzar; Tarceva

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Herbert J. Zeh, III MD, FACS

OTHER

Sponsor Role: lead

Responsible Party

Herbert J. Zeh, III MD, FACS

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Herb Zeh, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Cancer Centers Network

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

06-016

Identifier Type: -

Identifier Source: org_study_id