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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
688

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 1999

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2000

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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