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

NCT ID: NCT00025480

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31

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.

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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

tipifarnib

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Principal Investigators

Stephen Michael Hahn, MD

Role: STUDY_CHAIR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC-NCI-5150

Identifier Type: -

Identifier Source: secondary_id

NCI-5150

Identifier Type: -

Identifier Source: secondary_id

CDR0000068965

Identifier Type: -

Identifier Source: org_study_id