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R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer



R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer

For Condition: stage 4 non-small cell lung cancer,recurrent non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Mayo Clinic Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have recurrent or metastatic non-small cell lung cancer.
Details: OBJECTIVES: I. Assess the response rate of patients with recurrent or metastatic non-small cell lung cancer when treated with R115777. II. Determine the clinical toxicities of this treatment in these patients. III. Assess the overall survival and time to progression of this patient population when treated with this regimen. IV. Evaluate the inhibition of protein farnesylation in vivo and correlate such inhibition to plasma levels of R115777. V. Evaluate the occurrence of CYP450 polymorphisms and relate these to drug toxicity, pharmacokinetics, and response to this treatment in this patient population. PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 12 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed recurrent or metastatic non-small cell lung cancer (NSCLC) - Measurable disease; At least 20 mm in at least one dimension; Nonmeasurable is defined as any of the following: Bone lesions; Leptomeningeal disease; Ascites; Pleural/pericardial effusion; Inflammatory breast disease; Lymphangitis cutis/pulmonis; Abdominal masses not confirmed and followed by imaging techniques; Cystic lesions - No CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: No prior biologic, gene, or immunotherapy - Chemotherapy: No prior chemotherapy for NSCLC except low dose cisplatin as radiosensitizer - Endocrine therapy: Not specified - Radiotherapy: Prior radiotherapy to less than 25% of bone marrow allowed - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); AST no greater than 3 times ULN (no greater than 5 times ULN in case of hepatic metastases) - Renal: Creatinine no greater than 2 times ULN - Cardiovascular: No New York Heart Association class III or IV heart disease - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No uncontrolled infection; No other prior malignancy in past 5 years except adequately treated basal cell or squamous cell skin cancer or other adequately treated noninvasive carcinomas; No other concurrent severe underlying disease
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AlexAdjei,  Study Chair,  Mayo Clinic Cancer Center

Mayo Clinic Cancer Center
Rochester,  Minnesota,  55905
United States
 

University of Chicago Cancer Research Center
Chicago,  Illinois,  60637
United States
 


Additional Information:
Study ID Numbers:  CDR0000067978;  MAYO-982401,NCI-T99-0072
Study Start Date: July 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005989

Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer

2. Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

3. Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer

4. Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy

5. Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer

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R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
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