Status:
COMPLETED
Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
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-...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- AST or ALT \< 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00077519
Start Date
January 1 2004
End Date
December 31 2019
Last Update
April 15 2020
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283