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CompletedNCT00005989Updated Aug 4, 2011

R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer

A Phase 2 interventional study of tipifarnib in Lung Cancer, sponsored by Mayo Clinic. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-04.

Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have recurrent or metastatic non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

  • Assess the response rate of patients with recurrent or metastatic non-small cell lung cancer when treated with tipifarnib.
  • Determine the clinical toxicities of this treatment in these patients.
  • Assess the overall survival and time to progression of this patient population when treated with this regimen.
  • Evaluate the inhibition of protein farnesylation in vivo and correlate such inhibition to plasma levels of tipifarnib.
  • Evaluate the occurrence of CYP450 polymorphisms and relate these to drug toxicity, pharmacokinetics, and response to this treatment in this patient population.

OUTLINE: This is a multicenter study.

Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 12 months.

02

Conditions studied

  • Lung Cancer

Keywords

  • recurrent non-small cell lung cancer
  • stage IV non-small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

Browse Lung Neoplasms studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed recurrent or metastatic non-small cell lung cancer (NSCLC)
  • Measurable disease

    • At least 20 mm in at least one dimension
    • Nonmeasurable is defined as any of the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses not confirmed and followed by imaging techniques
      • Cystic lesions
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3

Hepatic

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST no greater than 3 times ULN (no greater than 5 times ULN in case of hepatic metastases)

Renal

  • Creatinine no greater than 2 times ULN

Cardiovascular

  • No New York Heart Association class III or IV heart disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled infection
  • No other prior malignancy in past 5 years except adequately treated basal cell or squamous cell skin cancer or other adequately treated noninvasive carcinomas
  • No other concurrent severe underlying disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic, gene, or immunotherapy

Chemotherapy

  • No prior chemotherapy for NSCLC except low dose cisplatin as radiosensitizer

Endocrine therapy

  • Not specified

Radiotherapy

  • Prior radiotherapy to less than 25% of bone marrow allowed

Surgery

  • Not specified
05

Study design

Phase
Phase 2
Primary purpose
Treatment

Interventions

  • Drugtipifarnib
06

Study locations

3 sites
  • Mayo Clinic in Florida
    Jacksonville, Florida, United States
  • University of Chicago Cancer Research Center
    Chicago, Illinois 60637, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00005989
Lead sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
First posted
Apr 20, 2004
Start date
Nov 2002
Primary completion
Jul 2007
Completion
Jul 2007
Last update
Aug 4, 2011

Study contacts

Julian Molina, MD
study chair · Mayo Clinic
Elizabeth Johnson, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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