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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Davis
Study ID
NCT00810719
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Dec 18, 2008
Start date
Apr 30, 2009
Status verified
Mar 2017
Primary completion
Jan 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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 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.

Primary Outcome Measure

Progression Free Survival [ Time Frame: Up to 36 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
USC/Norris Comprehensive Cancer Center and HospitalLos AngelesCalifornia90089-9181-
University of California Davis Cancer CenterSacramentoCalifornia95817-

Find similar trials in Los Angeles, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
USC/Norris Comprehensive Cancer Center and Hospital· Los Angeles, CAUniversity of California Davis Cancer Center· Sacramento, CA

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