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

Alternate Title

Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI MAYO-MC0123 NCI-5641, NCT00055757, 5641

Objectives

1. Determine the response rate of patients with stage IIIB or IV non-small cell lung cancer treated with tipifarnib, gemcitabine, and cisplatin.
2. Determine the efficacy of this regimen, in terms of time to disease progression, time to treatment failure, and survival, in these patients.
3. Determine the duration of response in patients treated with this regimen.
4. Determine the toxicity of this regimen in these patients.
5. Correlate polymorphism expression in candidate genes with clinical endpoints and toxicity in patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Alex Adjei, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 507-284-2511 Email: adjei.alex@mayo.edu

Registry Information
Official Title		A Phase II Trial of R11577, a Farnesyl Transferase Inhibitor, in Combination with Gemcitabine and Cisplatin in Advanced Non-Small Cell Lung Cancer (NSCLC)
Trial Start Date		2002-11-06
Registered in ClinicalTrials.gov		NCT00055757
Date Submitted to PDQ		2003-01-14
Information Last Verified		2004-08-11
NCI Grant/Contract Number		NO1-CM17104, P30-CA15083

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