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Tipifarnib Plus Radiation Therapy After Combination Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT00025480
Collaborator
National Cancer Institute (NCI) (NIH)
12
Enrollment
1
Location

Study Details

Study Description

Brief Summary

RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by making tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing and may also make tumor cells more sensitive to radiation therapy.

PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when given together with radiation therapy after combination chemotherapy in treating patients with stage III non-small cell lung cancer.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose and dose-limiting toxicity of tipifarnib given concurrently with radiotherapy after induction chemotherapy comprising paclitaxel and carboplatin and followed by maintenance therapy with tipifarnib in patients with stage IIIA or IIIB non-small cell lung cancer.

  • Determine the tumor response at 3 months in patients treated with this regimen.

OUTLINE: This is multicenter, dose-escalation study of tipifarnib.

Patients receive induction chemotherapy comprising carboplatin IV over 30 minutes on day 1 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses.

Beginning 4-6 weeks after the completion of induction chemotherapy, patients receive oral tipifarnib twice daily for 7 weeks. Patients undergo radiotherapy once daily 5 days a week for 7 weeks beginning 3 days after the start of tipifarnib. After completion of radiotherapy, patients receive oral tipifarnib twice daily for 4 days and then once daily for 4 days.

Cohorts of 3-6 patients receive escalating doses of tipifarnib while receiving radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Beginning 4-6 weeks after the completion of radiotherapy and tipifarnib, patients receive maintenance therapy comprising oral tipifarnib twice daily on days 1-21. Maintenance therapy repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3, 6, and 12 months.

PROJECTED ACCRUAL: Approximately 9-12 patients will be accrued for this study within 1 year.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Primary Purpose:
Treatment
Official Title:
A Phase I Trial of Farnesyltransferase Inhibitor, R115777 (NSC # 702818) and Radiotherapy in Patients With Non-Small Cell Lung Cancer
Study Start Date :
Aug 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed non-small cell lung cancer

    • Locally advanced (stage IIIA or IIIB) disease requiring radiotherapy

    • No malignant pleural effusion

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • ECOG 0-2
    Life expectancy:
    • Not specified
    Hematopoietic:

    • WBC at least 3,500/mm^3

    • Platelet count at least 100,000/mm^3

    Hepatic:

    • Bilirubin no greater than 1.5 mg/dL

    • No grade 2 or greater elevation of liver function tests

    Renal:
    • Creatinine no greater than 1.5 times normal
    Pulmonary:
    • FEV_1 at least 600 cc
    Other:

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • HIV negative

    • No grade 3 or 4 peripheral neuropathy

    • No known allergy to imidazole drugs (e.g., ketoconazole, miconazole, econazole, or terconazole)

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Not specified
    Chemotherapy:
    • Up to 2 prior or concurrent carboplatin and paclitaxel chemotherapy regimens allowed
    Endocrine therapy:
    • Not specified
    Radiotherapy:

    • See Disease Characteristics

    • No prior thoracic radiotherapy

    Surgery:
    • At least 3 weeks since prior exploratory thoracotomy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104-4283

    Sponsors and Collaborators

    • Abramson Cancer Center of the University of Pennsylvania
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Stephen Michael Hahn, MD, Abramson Cancer Center of the University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00025480
    Other Study ID Numbers:
    • CDR0000068965
    • UPCC-NCI-5150
    • NCI-5150
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Mar 13, 2019
    Last Verified:
    Apr 1, 2007
    Keywords provided by , ,
    stage IIIA non-small cell lung cancer
    stage IIIB non-small cell lung cancer
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Paclitaxel
    Carboplatin
    Tipifarnib

    Study Results

    No Results Posted as of Mar 13, 2019