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R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005843
First Posted: March 5, 2004
Last Update Posted: February 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
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.

Condition Intervention Phase
Pancreatic Cancer Drug: tipifarnib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of R115777 (NSC-702818), an Inhibitor of Farnesyl Protein Transferase, in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 40
Study Start Date: May 2000
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: tipifarnib

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005843


Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: Neal J. Meropol, MD Fox Chase Cancer Center
  More Information

Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005843     History of Changes
Other Study ID Numbers: NCI-2012-02335
FCCC-00005
NCI-45
CDR0000067859 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: June 2, 2000
First Posted: March 5, 2004
Last Update Posted: February 11, 2013
Last Verified: April 2007

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Tipifarnib
Antineoplastic Agents