Gemcitabine And Erlotinib In Treating Patients With Metastatic Or Recurrent Pancreatic Cancer

Study Overview

Gemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with erlotinib works in treating patients with metastatic or recurrent pancreatic cancer.

OUTLINE: This is a multicenter study. Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15 and oral erlotinib hydrochloride on days 2-5, 9-12, and 16-26. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Archived tumor tissue samples are analyzed for the expression of EGFR, HER3, HER2, downstream signaling molecules, and other molecular markers by immunohistochemistry and RT-PCR. The presence of aberrant gene copy numbers (amplification and polysomy) for EGFR, HER3, and HER2 are determined by FISH. Blood samples are collected at baseline and periodically during study for polymorphism analysis and correlative molecular analysis of surrogate endpoint biomarkers. After completion of study therapy, patients are followed every 3 months.

Pancreatic Cancer

DRUG: Erlotinib
DRUG: gemcitabine

UCDCC#211
232494 (OTHER Identifier) (OTHER: UC Davis)
OSI 4132s (OTHER Identifier) (OTHER: Genentech)
P30CA093373 (U.S. NIH Grant/Contract)

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 2008-12-17	Results First Submitted 2017-01-13	Last Update Submitted that met QC Criteria 2018-01-05
First Submitted that Met QC Criteria 2008-12-17	Results First Submitted that Met QC Criteria 2017-01-13	Last Update Posted (ACTUAL) 2018-01-10
First Posted (ACTUAL) 2008-12-18	Results First Posted 2017-03-07	Last Verified 2017-03

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 The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 da	DRUG: Erlotinib Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26. DRUG: gemcitabine The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 da

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Gemcitabine and Erlotinib

The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 da

DRUG: Erlotinib

Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.

DRUG: gemcitabine

The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 da

Primary Outcome Measures	Measure Description	Time Frame
Progression Free Survival	Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	Up to 36 months

Secondary Outcome Measures	Measure Description	Time Frame
Response Rate	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	Up to 36 months
Overall Survival	Overall survival will be followed for survival every three months until documented progression, death or study termination. If a participant is still alive, survival time is censored at the time of last follow-up.	Up to 36 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:

Histologically or cytologically confirmed locally advanced, metastatic or recurrent pancreatic carcinoma
Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
No prior chemotherapy for metastatic or recurrent disease is allowed. Prior adjuvant chemotherapy is allowed provided that patients did not receive gemcitabine and the chemotherapy was completed > six months prior to initiation of study therapy. Prior erlotinib therapy is not allowed
Available tumor specimen that was obtained at the time of diagnosis and/or prior to study entry is highly encouraged
Age ≥ 18 years
Life expectancy greater than 3 months
Zubrod performance status ≤ 2
Patients must have normal organ and marrow function as defined below:
leukocytes ≥ 3,000/μL
absolute neutrophil count ≥ 1,500/ μL
platelets ≥ 100,000/ μL
total bilirubin ≤ 1.5 X institutional upper limit of normal
AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal, unless the liver is involved with tumor, in which case the AST/ALT must be ≤ 5 X institutional upper limit of normal
creatinine clearance ≥ 50 mL/min/1.73 m2, as measured by 24hour collection OR
creatinine ≤ 1.5 X institutional upper limit of normal
The effects of erlotinib and gemcitabine on the developing human fetus at the recommended therapeutic doses are unknown. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
Ability to understand and the willingness to sign a written informed consent document

Patients may not be receiving any other investigational agents.
Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib or gemcitabine.
Secondary primary malignancy. Concurrent or history of another malignancy < 5 years.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because erlotinib and gemcitabine have the potential for teratogenic or abortifacient effects. Breastfeeding should be discontinued if the mother is treated with study drugs.
Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy.

Collaborators and Investigators

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

National Cancer Institute (NCI)
Genentech, Inc.

Investigators

PRINCIPAL_INVESTIGATOR: Primo N. Lara, MD, University of California, Davis

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

Semrad T, Barzi A, Lenz HJ, Hutchins IM, Kim EJ, Gong IY, Tanaka M, Beckett L, Holland W, Burich RA, Snyder-Solis L, Mack P, Lara PN Jr. Pharmacodynamic separation of gemcitabine and erlotinib in locally advanced or metastatic pancreatic cancer: therapeutic and biomarker results. Int J Clin Oncol. 2015 Jun;20(3):518-24. doi: 10.1007/s10147-014-0730-2. Epub 2014 Aug 5.

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