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Home > "T" Clinical Trials Conditions > Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer
Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer
For Condition: stage 3 pancreatic cancer,stage 2 pancreatic cancer,recurrent pancreatic cancer
Status: Recruiting
Sponsor(s): University of Pennsylvania Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and may make them more sensitive to radiation therapy. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining tipifarnib with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining tipifarnib with radiation therapy in treating patients who have unresectablelocally advancedpancreatic cancer.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose and dose-limiting toxic effects of tipifarnib when administered with radiotherapy in patients with unresectable locally advanced pancreatic cancer. Secondary - Determine the 3-month clinical response in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of tipifarnib. Patients receive oral tipifarnib once or twice daily on weeks 1-8. Patients also undergo concurrent radiotherapy daily, 5 days a week, on weeks 2-8. Cohorts of 3-6 patients receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 1, 3, and 6 months. PROJECTED ACCRUAL: A total of 8-18 patients will be accrued for this study within 12-15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed pancreatic cancer - Locally advanced disease - Unresectable disease requiring radiotherapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - Liver function tests < grade 2 elevation - Bilirubin 2.0 mg/dL* NOTE: *Prior biliary stent procedure to normalize bilirubin levels allowed Renal - Creatinine 1.5 times normal Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No peripheral neuropathy grade 2 - No known allergy to imidazole drugs, including any of the following: - Clotrimazole - Ketoconazole - Miconazole - Econazole - Fenticonazole - Isoconazole - Sulconazole - Tioconazole - Terconazole PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior experimental or standard chemotherapy and recovered - No concurrent experimental chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior upper abdominal radiotherapy Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenHahn, Principal Investigator, University of Pennsylvania Cancer Center
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Stephen Hahn 215-662-7296
Additional Information:
Study ID Numbers: CDR0000352182; UPCC-20203,NCI-6407
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077519
Other Recurrent Pancreatic Cancer Studies:
1. Paclitaxel and Bryostatin-1 in Treating Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
2. Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer
3. Phase I Study of Vaccination With MUC-1 Antigen and Immunologic Adjuvant SB AS-2 in Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer
4. Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
5. Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer
Related Studies:
Other recurrent pancreatic cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer
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