A Phase I Trial of Farnesyltransferase Inhibitor, R115777 (NSC # 702818) and Radiotherapy in Patients With Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase I Trial of Farnesyltransferase Inhibitor, R115777 (NSC # 702818) and Radiotherapy in Patients With Non-Small Cell Lung Cancer
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Stephen Michael Hahn, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000068965
NCT ID:
NCT00025480
Start Date:
August 2001
Completion Date:
Related Keywords:
- Lung Cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
