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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 3

Conditions: Pancreatic Neoplasms

Treatments: Drug: Gemcitabine with Placebo; Drug: Gemcitabine with R115777

Study type: Interventional

Funder types: Industry

Identifiers

NCT00005648

R115777-INT-11

CR003976

Details and patient eligibility

About

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

Full 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.

Enrollment: 688 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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688 participants in 2 patient groups, including a placebo group

001

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine with R115777

002

Placebo Comparator group

Description:

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

Treatment:

Drug: Gemcitabine with Placebo