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Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer Clinical research trials and Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer. Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer  Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
For Condition: squamous cell lung cancer,recurrent non-small cell lung cancer,large cell lung cancer,stage 4 non-small cell lung cancer,adenocarcinoma of the lung,stage 3B non-small cell lung cancer
Status: Terminated
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining lonafarnib with gemcitabine may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining lonafarnib with gemcitabine in treating patients who have advanced stage III, stage IV, or recurrent non-small cell lung cancer.
Details: OBJECTIVES: - Determine the overall survival of patients with stage IIIB or IV, advanced primary or recurrent non-small cell lung cancer treated with lonafarnib and gemcitabine. - Determine response (confirmed and unconfirmed and complete and partial [in patients with measurable disease]) in patients treated with this regimen. - Determine the progression-free survival of patients treated with this regimen. - Determine the toxic effects of this regimen in these patients. - Correlate clinical outcome with p53 mutational status in tumor tissue of patients treated with this regimen. - Correlate baseline basal expression levels of nucleotide excision repair gene ERCC1 with response in patients treated with this regimen. - Correlate biologic activity of lonafarnib and inhibition of prelamin A farnesylation in buccal brushings submitted on SWOG-S9925 with response in patients before and after treatment with this regimen. OUTLINE: This is a multicenter study. Patients receive oral lonafarnib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 16 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed primary non-small cell lung cancer meeting one of the following staging criteria: - Stage IIIB with T4 lesion due to malignant pleural effusion - Stage IIIB with T4 lesion due to separate tumor nodules in the same lobe (any N, M0) - Stage IV - Recurrent disease - The following subtypes are eligible: - Adenocarcinoma - Large cell carcinoma - Squamous cell carcinoma - Unspecified - Not amenable to radiotherapy or surgery - Measurable or non-measurable disease by CT scan, MRI, x-ray, physical exam, or nuclear exam - Measurable disease must be outside area of prior surgical resection - Must have received 1 prior chemotherapy regimen - Chemotherapy administered in the neoadjuvant or adjuvant setting counts as 1 prior regimen - No brain metastases unless controlled after surgical resection or radiotherapy/radiosurgery - Concurrent enrollment on SWOG-S9925 (Lung Cancer Specimen Repository) allowed PATIENT CHARACTERISTICS: Age - Not specified Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN - SGOT or SGPT no greater than 1.5 times ULN Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - QTc no greater than 500 msec by EKG Other - Not pregnant or nursing - Fertile patient must use effective non-hormonal method of contraception - No grade 1 or greater symptomatic sensory neuropathy - Able to swallow oral medication - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent biologic therapy Chemotherapy - See Disease Characteristics - At least 3 weeks since prior chemotherapy - No prior gemcitabine Endocrine therapy - No concurrent hormonal therapy, including hormonal contraception Radiotherapy - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered - No concurrent radiotherapy Surgery - See Disease Characteristics - At least 3 weeks since prior thoracic or other major surgery and recovered Other - No prior lonafarnib
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TarekMekhail, Study Chair, Cleveland Clinic Cancer Center
Additional Information:
Study ID Numbers: CDR0000271218; SWOG-S0129
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055796
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
2. Acridine Carboxamide in Treating Patients With Advanced Non-small Cell Lung Cancer
3. Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
4. Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
5. Suramin and Either Docetaxel or Gemcitabine in Treating Patients With Stage IIIB or Stage IV Platinum-Refractory Non-Small Cell Lung Cancer
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Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
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