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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Herbert J. Zeh, III MD, FACS
Study ID
NCT00336700
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Gemcitabine — DRUG
    1500mg/m2 IV over 150 min IV q 2 weeks 4 months
  • Erlotinib — DRUG
    150 mg/d Daily, oral 12 months

Study Details

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.

Key Dates

First listed
Jun 14, 2006
Start date
Jun 30, 2006
Status verified
Jul 2016
Primary completion
Oct 31, 2011
Completion
Nov 30, 2011

Study Design

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

Arms

  • 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

Primary Outcome Measure

Recurrence Free Survival (RFS) [ Time Frame: Up to 60 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Cancer Centers NetworkPittsburghPennsylvania15232-

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