Gemcitabine With or Without Capecitabine and/or Radiation Therapy or Gemcitabine With or Without Erlotinib in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT00634725
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • capecitabine — DRUG
  • erlotinib hydrochloride — DRUG
  • gemcitabine hydrochloride — DRUG
  • laboratory biomarker analysis — OTHER
  • radiation therapy — RADIATION

Study Details

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which regimen of chemotherapy with or without erlotinib and/or radiation therapy is most effective in treating pancreatic cancer. PURPOSE: This randomized phase III trial is studying giving gemcitabine together with or without capecitabine and/or radiation therapy to see how well it works compared with giving gemcitabine together with or without erlotinib in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Key Dates

First listed
Mar 13, 2008
Start date
Feb 29, 2008
Status verified
Nov 2012
Primary completion
Feb 28, 2013
Completion
Sep 30, 2014

Study Design

Enrollment
820 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1 (A1) - Gemcitabine
    Gemcitabine 2 months, then stop until progression
  • Experimental: Arm 2 (B1) Gemcitabine + Erlotinib
    B1 Gemcitabine + Erlotinib (100mg/d) 2 months, then erlotinib maintenance (150 mg/d)until progression
  • Experimental: Arm 3 (A2) CRT
    A2 CRT then stop until progression
  • Experimental: Arm 4 (B2) CRT then erlotinib
    B2 CRT then erlotinib maintenance (150mg/d) until progression

Primary Outcome Measure

Overall survival [ Time Frame: from the date of the first randomization to the date of patient death,due to any cause, or to the last date the patient was known to be alive, assessed up to 8 years after the beginning of the study ]

Related Studies