Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI UPCC-NCI-5150 NCI-5150, NCT00025480, 5150

Objectives

1. 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.
2. Determine the tumor response at 3 months in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed non-small cell lung cancer
  • Locally advanced (stage IIIA or IIIB) disease requiring radiotherapy



• No malignant pleural effusion

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm³
• Platelet count at least 100,000/mm³

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:

• FEV₁ 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)

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Abramson Cancer Center of the University of Pennsylvania

Stephen Michael Hahn, MD, Protocol chair		Ph: 215-662-7296 Email: hahn@xrt.upenn.edu

Registry Information
Official Title		A Phase I Trial of Farnesyltransferase Inhibitor, R115777 (NSC # 702818) and Radiotherapy in Patients with Non-Small Cell Lung Cancer
Trial Start Date		2001-08-13
Registered in ClinicalTrials.gov		NCT00025480
Date Submitted to PDQ		2001-08-10
Information Last Verified		2007-04-29
NCI Grant/Contract Number		CM17106, CA16520

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