NCT00005648

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
688

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 1999

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 21, 2004

Completed
Last Updated

May 19, 2011

Status Verified

October 1, 2010

First QC Date

May 2, 2000

Last Update Submit

May 17, 2011

Conditions

Pancreatic Neoplasms

Keywords

Stage II pancreatic cancerStage III pancreatic cancerRecurrent pancreatic cancerAdenocarcinoma of the pancreasStage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival of patients with advanced pancreatic cancer after treatment with gemcitabine with or without R115777.

    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 Outcomes (2)

  • Evaluation of Quality of Life (QOL) parameters in patients with advanced pancreatic cancer after treatment with gemcitabine with or without R115777

    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

    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)

Study Arms (2)

001

EXPERIMENTAL

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

002

PLACEBO COMPARATOR

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

Interventions

Gemcitabine with R115777DRUG

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

001
Gemcitabine with PlaceboDRUG

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

002

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabinetipifarnib

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 2, 2000

First Posted

May 21, 2004

Study Start

November 1, 1999

Study Completion

November 1, 2003

Last Updated

May 19, 2011

Record last verified: 2010-10