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Combination Chemotherapy Followed By Tipifarnib Plus Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Combination Chemotherapy Followed By Tipifarnib Plus Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Followed By Tipifarnib Plus Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy Followed By Tipifarnib Plus Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Combination Chemotherapy Followed By Tipifarnib Plus Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer. Combination Chemotherapy Followed By Tipifarnib Plus Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy Followed By Tipifarnib Plus Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Combination Chemotherapy Followed By Tipifarnib Plus Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed By Tipifarnib Plus Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer  Combination Chemotherapy Followed By Tipifarnib Plus Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Combination Chemotherapy Followed By Tipifarnib Plus Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
For Condition: stage 3A non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: Recruiting
Sponsor(s): University of Pennsylvania Cancer Center , 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as tipifarnib may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by tipifarnib plus radiation therapy in treating patients who have stage III non-small cell lung cancer.
Details: 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. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenHahn, Study Chair, University of Pennsylvania Cancer Center
Massey Cancer Center at Virginia Commonwealth University *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting Theodore Chung 804-828-7232
Chester County Hospital *Recruiting*
West Chester, Pennsylvania, 19380
United States
Recruiting Roseann Romito 610-431-5530
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Stephen Hahn 215-662-7296
Additional Information:
Study ID Numbers: CDR0000068965; UPCC-NCI-5150,NCI-5150
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025480
Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
2. Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
3. Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
4. Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
5. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
Related Studies:
Other stage 3B non-small cell lung cancer Clinical Trials
Other Virginia Clinical Trials
Other Richmond Clinical Trials
Combination Chemotherapy Followed By Tipifarnib Plus Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
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