Gemcitabine With or Without Tipifarnib (R115777) in Treating Patients With Advanced Pancreatic Cancer

May 17, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Phase III, Double-Blind, Placebo Controlled Trial of Gemcitabine Plus Placebo Versus Gemcitabine Plus R115777 in Patients With Advanced Pancreatic Cancer

The purpose of this study is to compare the effectiveness of gemcitabine with or without tipifarnib (R115777) in patients who have advanced pancreatic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized (study drug assigned by chance), double-blind (neither the investigator or patient will know the identity of the assigned treatment) to compare the overall survival of patients with advanced pancreatic cancer after treatment with gemcitabine with and without tipifarnib (referred to as R115777). Gemcitabine is an approved chemotherapy agent administered intravenously (iv) (though a vein) for patients with advanced pancreatic cancer. R115777 is an orally (by mouth) administered investigational drug that is being tested in combination with gemcitabine for the treatment of patients with advanced pancreatic cancer. Patients will continue to receive treatment with gemcitabine and R115777 (or placebo) unless disease progression or unacceptable toxicity is observed. All patients in the study will be followed for study assessments and safety for up to the 5 years, the start of further treatment, or death (whichever comes first). R115777 (or matching placebo) 200 mg will be orally administered at intervals of approximately 12 hours daily throughout the study. Gemcitabine will be administered iv at a starting dose of 1000 mg/m2 every week for the first 7 weeks, followed by 1 week rest, and then every 3 out of 4 weeks thereafter. Treatment with gemcitabine and tipifarnib (or placebo) will continue for up to 5 years (or until the start of further treatment) in the absence of disease progression or unacceptable toxicity.

Study Type

Interventional

Enrollment (Actual)

688

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathological (confirmed by biopsy) diagnosis of pancreatic cancer
  • have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1 (defined as a patient who does not have symptoms of pancreatic cancer and is fully active or who has symptoms but is able to light work)

Exclusion Criteria:

  • Have absolute neutrophil (white blood cell) count, platelet count (blood clotting factors), or results from liver function tests considered by the investigator to be significantly abnormal
  • Newly diagnosed disease that has the potential for curative surgical resection
  • Prior therapy with any chemotherapy, or any other systemic therapy for pancreatic cancer
  • Have cardiovascular disease considered by the investigator to be uncontrolled or severe

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 001
Gemcitabine with R115777 R115777 200 mg oral twice daily at 12-hour intervals throughout the study coadministered with gemcitabine 1000 mg/m2 iv every week for the first 7 weeks followed by 1 week rest and then every 3 out of 4 weeks thereafter for up to 5 years
Drug: Gemcitabine with R115777
R115777 200 mg, oral, twice daily at 12-hour intervals throughout the study coadministered with gemcitabine, 1000 mg/m2, iv, every week for the first 7 weeks, followed by 1 week rest, and then every 3 out of 4 weeks thereafter for up to 5 years
Placebo Comparator: 002
Gemcitabine with Placebo Placebo oral twice daily at 12-hour intervals throughout the study coadministered with gemcitabine 1000 mg/m2 iv every week for the first 7 weeks followed by 1 week rest and then every 3 out of 4 weeks thereafter for up to 5 years
Drug: Gemcitabine with Placebo
Placebo, oral, twice daily at 12-hour intervals throughout the study coadministered with gemcitabine, 1000 mg/m2, iv, every week for the first 7 weeks, followed by 1 week rest, and then every 3 out of 4 weeks thereafter for up to 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival of patients with advanced pancreatic cancer after treatment with gemcitabine with or without R115777.
Time Frame: From the date of randomization to the date of death or to the last followup date for patients who were still alive at the clinical cutoff date (ie, for up to 5 years)
From the date of randomization to the date of death or to the last followup date for patients who were still alive at the clinical cutoff date (ie, for up to 5 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of Quality of Life (QOL) parameters in patients with advanced pancreatic cancer after treatment with gemcitabine with or without R115777
Time Frame: From the date of randomization to the date of death or to the last followup date for patients who were still alive at the clinical cutoff date (ie, for up to 5 years)
From the date of randomization to the date of death or to the last followup date for patients who were still alive at the clinical cutoff date (ie, for up to 5 years)
The incidence of adverse events with respect to severity and relationship to the study medication as a measure of safety
Time Frame: From the date of randomization to the date of death or to the last followup date for patients who were still alive at the clinical cutoff date (ie, for up to 5 years)
From the date of randomization to the date of death or to the last followup date for patients who were still alive at the clinical cutoff date (ie, for up to 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1999

Study Completion (Actual)

November 1, 2003

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

May 20, 2004

First Posted (Estimate)

May 21, 2004

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 17, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003976
  • R115777-INT-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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