Status:
TERMINATED
Intensity-Modulated Radiation Therapy and Gemcitabine in Treating Patients With Locally Advanced Pancreatic Cancer
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
The study was terminated early due to slow accrual and only the phase I portion of hte study was opened. The phase of the study has been revised to only a phase I study. OBJECTIVES: * To determine t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00878657
Start Date
April 1 2009
End Date
October 1 2013
Last Update
May 5 2014
Active Locations (1)
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1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903