Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

Part of paid clinical trials in La Jolla, California.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00733746
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • erlotinib hydrochloride — DRUG
    oral administration
  • gemcitabine hydrochloride — DRUG
    Intravenous administration
  • therapeutic conventional surgery — PROCEDURE

Study Details

PURPOSE: This phase II trial is studying how well gemcitabine and erlotinib work when given before and after surgery in treating patients with pancreatic cancer that can be removed by surgery. 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 and erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.

Key Dates

First listed
Aug 13, 2008
Start date
Apr 30, 2009
Status verified
Oct 2019
Primary completion
Nov 30, 2015
Completion
Jun 15, 2019

Study Design

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

Arms

  • Experimental: Neoadjuvant therapy + Surgery + Adjuvant therapy
    As part of neoadjuvant therapy, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity. Within 3-6 weeks after completion of neoadjuvant therapy, patients undergo pancreaticoduodenectomy and patients receive gemcitabine hydrochloride and erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post surgery.

Primary Outcome Measure

Overall Survival at 2 Years [ Time Frame: At 2 years post-registration ]

Locations (23)

FacilityCityStateZIPSite coordinators
Rebecca and John Moores UCSD Cancer CenterLa JollaCalifornia92093-0658-
Kaiser Permanente Medical Center - Los AngelesLos AngelesCalifornia90027-
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrangeCalifornia92868-
St. Vincent's Medical CenterBridgeportConnecticut06606-
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakelandFlorida33805-
St. Francis Hospital Cancer Care ServicesIndianapolisIndiana46237-
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimoreMaryland21215-
St. Agnes Hospital Cancer CenterBaltimoreMaryland21229-
University of Mississippi Cancer ClinicJacksonMississippi39216-
Methodist Estabrook Cancer CenterOmahaNebraska68114-
NYU Cancer Institute at New York University Medical CenterNew YorkNew York10016-
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7295-
CCOP - DaytonDaytonOhio45420-
David L. Rike Cancer Center at Miami Valley HospitalDaytonOhio45409-
Samaritan North Cancer Care CenterDaytonOhio45415-
Charles F. Kettering Memorial HospitalKetteringOhio45429-
UVMC Cancer Care Center at Upper Valley Medical CenterTroyOhio45373-1300-
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsaOklahoma74136-
Providence Cancer Center at Providence Portland Medical CenterPortlandOregon97213-2967-
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburgSouth Carolina29303-
Surgical Oncology AssociatesNewport NewsVirginia23606-
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantownWest Virginia26506-
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadisonWisconsin53792-6164-

Find similar trials in La Jolla, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Rebecca and John Moores UCSD Cancer Center· La Jolla, CAKaiser Permanente Medical Center - Los Angeles· Los Angeles, CAChao Family Comprehensive Cancer Center at University of California Irvine Medical Center· Orange, CASt. Vincent's Medical Center· Bridgeport, CTLakeland Regional Cancer Center at Lakeland Regional Medical Center· Lakeland, FLSt. Francis Hospital Cancer Care Services· Indianapolis, IN

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