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

NCT00810719 | Completed Phase 2 Results DMC

• 4 other identifiers: UCDCC#211232494OSI 4132sP30CA093373
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Response Rate

  Up to 36 months

• Overall Survival

  Up to 36 months

Study Arms (1)

Gemcitabine and Erlotinib

EXPERIMENTAL

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 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.

Drug: Erlotinib; Drug: gemcitabine

Interventions

Erlotinib DRUG

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

Also known as: Tarceva

Gemcitabine and Erlotinib

gemcitabine DRUG

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 days) constitutes a cycle.

Also known as: Gemzar

Gemcitabine and Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator
• Genentech, Inc.: collaborator

Study Sites (2)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

• 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.

  PMID: 25091263 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Erlotinib Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Due to funding considerations, the study was closed after thirty participants were enrolled.

Results Point of Contact

• Title: Analyst
• Organization: University of California Davis

pkaujla@ucdavis.edu

916 734 0294

Study Officials

• Primo N. Lara, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: April 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 10, 2018
• Results First Posted: March 7, 2017

Record last verified: 2017-03

Locations

US (2)