Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer

Completed · Phase 1

Conditions studied: Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer

In brief

This phase I trial is studying the side effects and best dose of erlotinib when given together with gemcitabine and radiation therapy in treating patients with locally advanced unresectable pancreatic cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining erlotinib with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.

Key facts

Study ID: NCT00063947
Run by: National Cancer Institute (NCI)
People needed: 28
Starts: 2003-05-01
Last updated by the study team: 2013-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically or cytologically confirmed adenocarcinoma of the pancreas
Locally advanced, unresectable disease, defined by all of the following:
Obvious encasement of the celiac, hepatic, or superior mesenteric artery
Encasement of the portal or superior mesenteric vein not amenable to surgical resection
Extrapancreatic extension with or without regional lymph node involvement
No evidence of distant metastatic disease by staging laparoscopy*
Locally recurrent disease after prior curative surgery allowed provided the following are true:
No prior chemotherapy or radiotherapy
No evidence of distant metastatic disease by staging laparoscopy*
No islet cell pancreatic cancer or lymphoma or sarcoma of the pancreas
Measurable or evaluable disease
Primary pancreatic tumor is considered evaluable and not measurable disease
Lymph node mass considered measurable disease
No known brain metastases
Performance status - ECOG 0-2
More than 12 weeks
WBC ≥ 3,000/mm\^3
Absolute neutrophil count ≥ 1,500/mm\^3
Platelet count ≥ 100,000/mm\^3
Bilirubin ≤ 1.5 mg/dL
AST and ALT ≤ 2.5 times upper limit of normal
Creatinine ≤ 2.0 mg/dL
Creatinine clearance ≥ 60 mL/min
No symptomatic congestive heart failure
No unstable angina pectoris

Where it is running

Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.