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| Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00025480 |
Purpose
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 | Intervention | Phase |
|
Lung Cancer |
Drug: carboplatin Drug: paclitaxel Drug: tipifarnib Procedure: radiation therapy |
Phase I |
| MedlinePlus related topics: | Cancer Lung Cancer |
| ChemIDplus related topics: | Carboplatin Paclitaxel Tipifarnib |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Trial of Farnesyltransferase Inhibitor, R115777 (NSC # 702818) and Radiotherapy in Patients With Non-Small Cell Lung Cancer |
| Estimated Enrollment: | 12 |
| Study Start Date: | August 2001 |
OBJECTIVES:
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Pennsylvania | |||||
| Abramson Cancer Center of the University of Pennsylvania | |||||
| Philadelphia, Pennsylvania, United States, 19104-4283 | |||||
| University of Pennsylvania |
| National Cancer Institute (NCI) |
| Study Chair: | Stephen Michael Hahn, MD | University of Pennsylvania |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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| Study ID Numbers: | CDR0000068965, UPCC-NCI-5150, NCI-5150 |
| First Received: | October 11, 2001 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00025480 |
| Health Authority: | United States: Food and Drug Administration |
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