R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: tipifarnib

Study type: Interventional

Funder types: NIH

Identifiers

NCT00005843

FCCC-00005

NCI-2012-02335

NCI-45

CDR0000067859 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Arm I

Experimental group

Description:

Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment:

Drug: tipifarnib