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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Capecitabine; Erlotinib Hydrochloride; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the pancreas meeting the following criteria:

• De novo locally advanced disease

• Unresectable disease

• Stage III according to the UICC classification

• No distant metastases

• No localized stage IA-IIB or metastatic stage IV disease according to UICC classification

• Not considered for curative resection after pluridisciplinary discussion

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0-2

• Life expectancy ≥ 12 weeks

• Polynuclear neutrophils ≥ 1.5 x 10^9/L

• Platelets ≥ 100 x 10^9/L

• Hemoglobin ≥ 9 g/dL

• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

• For patients who have had a recent biliary drain and whose bilirubin is descending, a value of ≤ 3 times ULN is acceptable

• Creatinine ≤ 2 mg/dL

• AST and ALT ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 5 times ULN

• Albumin ≥ 25 g/L

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of therapy

Exclusion criteria:

• Diarrhea ≥ grade 2 and/or uncontrolled diarrhea

• Affiliated with a social security regime

• Unable to follow instructions for psychological, familial, or geographical reasons

• Allergic to one of the ingredients in erlotinib hydrochloride

• Cancer within the past 5 years, except for in situ cancer of the neck of the uterus or basal cell skin cancer

• Severe infection

• Ophthalmic disease (i.e., inflammation, keratopathy, or infection)

• Symptomatic coronary or cardiac insufficiency, myocardial infarction, or stroke within the last 6 months

• Unable to take oral treatments

• Gastrointestinal disorders that could be associated with absorption disorders

• Untreated gastric or duodenal ulcer

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy (including abdominal radiotherapy) or chemotherapy for any reason

• No prior anti-epidermal growth factor-receptor therapy