R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer
NCT ID: NCT00005843
Last Updated: 2013-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2000-05-31
Brief Summary
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Detailed Description
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I. Determine the safety and effectiveness of R115777 in patients with metastatic pancreatic cancer.
II. Determine the response rate, time to progression, and 6 month survival rate of these patients with this treatment regimen.
III. Assess the pharmacokinetics of this treatment regimen in this patient population.
OUTLINE: This is a multicenter study.
Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
tipifarnib
Interventions
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tipifarnib
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed adenocarcinoma of the pancreas
* Measurable metastatic disease No prior treatment for metastatic disease except immunotherapy (e.g., antibodies, vaccines, cytokines)
PATIENT CHARACTERISTICS:
* Age: 18 and over
* Performance status: ECOG 0-2
* WBC at least 4,000/mm3 OR granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Bilirubin no greater than 2.0 mg/dL
* SGOT/SGPT no greater than 2 times normal
* Creatinine no greater than 2.0 mg/dL OR creatinine clearance at least 50 mL/min
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after the study
* No concurrent illness or active infection which would preclude study
* No prior malignancy allowed unless disease free for the time period considered appropriate for cure of the specific cancer
* No history of allergies to imidazole compounds (e.g., fluconazole, ketoconazole, miconazole, itraconazole, clotrimazole)
PRIOR CONCURRENT THERAPY:
* No prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or thrombopoietin
* Primary neoadjuvant or adjuvant chemotherapy allowed at least 6 months prior to detection of metastatic disease
* Primary radiotherapy allowed at least 6 months prior to detection of metastatic disease
* No concurrent use of proton pump inhibitors (e.g., omeprazole)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Neal J. Meropol, MD
Role: STUDY_CHAIR
Fox Chase Cancer Center
Locations
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Cohen SJ, Ho L, Ranganathan S, Abbruzzese JL, Alpaugh RK, Beard M, Lewis NL, McLaughlin S, Rogatko A, Perez-Ruixo JJ, Thistle AM, Verhaeghe T, Wang H, Weiner LM, Wright JJ, Hudes GR, Meropol NJ. Phase II and pharmacodynamic study of the farnesyltransferase inhibitor R115777 as initial therapy in patients with metastatic pancreatic adenocarcinoma. J Clin Oncol. 2003 Apr 1;21(7):1301-6. doi: 10.1200/JCO.2003.08.040.
Other Identifiers
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FCCC-00005
Identifier Type: -
Identifier Source: secondary_id
NCI-45
Identifier Type: -
Identifier Source: secondary_id
CDR0000067859
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02335
Identifier Type: -
Identifier Source: org_study_id
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