R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005843
• Other study ID #: NCI-2012-02335
• Secondary ID: FCCC-00005NCI-45
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: February 8, 2013
• Start date: May 2000

Study information

• Verified date: April 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• tipifarnib

Locations

Country	Name	City	State
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 farnesyltransferas — View Citation