Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00766636
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Gemcitabine — DRUG
    Arm A: 1000 mg/M\^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Arm B: 400 mg/M\^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day.
  • Radiation Therapy — RADIATION
    1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy.
  • Erlotinib — DRUG
    100 mg daily by mouth on days 1-42.
  • Surgery — PROCEDURE
    Surgical removal of the pancreas and duodenum

Study Details

Primary Objective: To assess margin positive resection rate (R1 resection rate; defined as "tumor within 2 mm of surgical margin on final pathology report") in patients treated with preoperative chemotherapy (gemcitabine and erlotinib) with or without external-beam radiation therapy followed by pancreaticoduodenectomy for adenocarcinoma of the pancreatic head. Secondary Objectives: * To assess disease free survival * To assess overall survival * To assess patterns of local and distant failure

Key Dates

First listed
Oct 6, 2008
Start date
Sep 30, 2008
Status verified
Aug 2015
Primary completion
Nov 30, 2012

Study Design

Enrollment
5 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine + Erlotinib Without Radiation
    Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M\^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Surgical removal of the pancreas and duodenum.
  • Experimental: Gemcitabine + Erlotinib With Radiation
    Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M\^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.

Primary Outcome Measure

Difference in Positive Margin Resection (R1) Rate in Patients Undergo Surgery Between the Two Treatment Groups. [ Time Frame: Following resection performed at time of surgery, day 36 of treatment +/- 5 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
UT MD Anderson Cancer Center· Houston, TX

Related Studies