Intensity-Modulated Radiation Therapy and Gemcitabine in Treating Patients With Locally Advanced Pancreatic Cancer

• Status: Terminated
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy together with gemcitabine may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of intensity-modulated radiation therapy and to see how well it works when given together with gemcitabine in treating patients with locally advanced pancreatic cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Pathologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas, ampulla of Vater, or distal bile duct

• Locally advanced disease

• Medically inoperable, unresectable, or borderline resectable disease

• No previously resected disease (i.e., status post-pancreaticoduodenotomy)

• No non-adenocarcinoma, adenosquamous carcinoma, islet cell carcinoma, cyst adenoma, cystadenocarcinoma, carcinoid tumor, or duodenal carcinoma

• No lesions in the tail of the pancreas and/or splenic artery/vein involvement/encasement

• No recurrent or metastatic (M1) disease

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• WBC > 3,000/μL

• Platelet count > 100,000/μL

• Bilirubin ≤ 2 mg/dL

• SGOT < 5 times upper limit of normal (ULN)

• Creatinine < 1.5 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Adequate oral nutrition (e.g., ≥ 1,500 calories/day, stable weight for ≥ 2 weeks, and ≤ 5% weight loss)

• No active malignancy within the past 3 years, except cervical carcinoma in situ or nonmelanoma skin cancer that has been removed

• No severe, active comorbidity, including any of the following:

• Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months

• Transmural myocardial infarction within the past 6 months

• Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration

• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within the past month or precluding study therapy at the time of study registration

• Active hepatitis, decompensated cirrhosis, or clinically significant liver failure

• Other severe comorbid condition, as determined by the principal investigator

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy

• No prior radiotherapy to any upper abdominal site

• No concurrent prophylactic colony-stimulating factors during radiotherapy

• No concurrent warfarin

• No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, surgery for cancer, or experimental therapy