A Phase II Study Of Gemcitabine And Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer

Study Overview

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

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.

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.

Pancreatic Cancer

DRUG: Gemcitabine
DRUG: Erlotinib

06-016

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-06-12	Results First Submitted 2015-12-23	Last Update Submitted that met QC Criteria 2016-07-27
First Submitted that Met QC Criteria 2006-06-12	Results First Submitted that Met QC Criteria 2016-07-27	Last Update Posted (ESTIMATED) 2016-09-19
First Posted (ESTIMATED) 2006-06-14	Results First Posted 2016-09-19	Last Verified 2016-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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	DRUG: Gemcitabine 1500mg/m2 IV over 150 min IV q 2 weeks 4 months DRUG: Erlotinib 150 mg/d Daily, oral 12 months

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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

DRUG: Gemcitabine

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

DRUG: Erlotinib

150 mg/d Daily, oral 12 months

Primary Outcome Measures	Measure Description	Time Frame
Recurrence Free Survival (RFS)	The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death.	Up to 60 months
1-year Recurrence Free Survival (RFS)		Up to 60 months
2-year Recurrence Free Survival (RFS)		Up to 60 months

Secondary Outcome Measures	Measure Description	Time Frame
Estimated 1&2 Year Overall Survival (OS)	Time from from date of first study therapy to to death from any cause.	Up to 60 months
Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)	Percentage of participants with expression of epidermal growth factor receptor (EGFR) expression in the resected tumors was assessed by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC).	Up to 60 months
KRAS Mutational Status	KRAS mutation status in resected tumor specimens.	Up to 60 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Genentech, Inc.

Investigators

PRINCIPAL_INVESTIGATOR: Herb Zeh, M.D., University of Pittsburgh

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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