Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy such as gemcitabine and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining tipifarnib with combination chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining tipifarnib with gemcitabine and cisplatin in treating patients who have stage III or stage IV non-small cell lung cancer.

Further Study Information

OBJECTIVES:

• Determine the response rate of patients with stage IIIB or IV non-small cell lung cancer treated with tipifarnib, gemcitabine, and cisplatin.

• Determine the efficacy of this regimen, in terms of time to disease progression, time to treatment failure, and survival, in these patients.

• Determine the duration of response in patients treated with this regimen.

• Determine the toxicity of this regimen in these patients.

• Correlate polymorphism expression in candidate genes with clinical endpoints and toxicity in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral tipifarnib twice daily on days 1-14, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with at least stable disease may continue to receive oral tipifarnib alone twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 5 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer (NSCLC), meeting one of the following staging criteria:

• Stage IIIB with pleural effusion

• Stage IIIB and not a candidate for combination therapy with radiotherapy and chemotherapy

• Stage IV

• Measurable disease

• At least one lesion at least 2.0 cm in diameter

• No CNS metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

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

• Hemoglobin greater than 10.0 g/dL

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 5 times ULN

• AST no greater than 3 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• No New York Heart Association class III or IV heart disease

• No known peripheral vascular disease

• No history of deep vein thrombosis

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled infection

• No other severe, underlying disease that would preclude study participation

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma

• No grade 2 or greater preexisting peripheral neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior immunotherapy

• No prior biologic therapy

• No prior gene therapy

Chemotherapy

• See Disease Characteristics

• No prior chemotherapy for NSCLC except therapy used as a radiosensitizer (i.e., low-dose weekly cisplatin and carboplatin/paclitaxel with radiotherapy)

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• See Chemotherapy

• No prior radiotherapy to more than 25% of the bone marrow

Surgery

• Not specified

Trial Contact Information

Trial Lead Organizations/Sponsors

Mayo Clinic Cancer Center

Alex A. Adjei

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00055757
Information obtained from ClinicalTrials.gov on December 14, 2011

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