R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer

Study Overview
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Brief Summary
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Phase II trial to study the effectiveness of R115777 in treating patients who have metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Phase II Trial of R115777 (NSC-702818), an Inhibitor of Farnesyl Protein Transferase, in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: tipifarnib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. | Drug: tipifarnib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer