|
Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical research trials and Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer. Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer clinical trial. Participants frequently get the best healthcare available for their Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer  Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
For Condition: stage 3A non-small cell lung cancer,stage 2 non-small cell lung cancer,recurrent non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fox Chase Cancer Center
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 damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced non-small cell lung cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan when administered with cisplatin and radiotherapy in patients with locally advanced non-small cell lung carcinoma. II. Determine the toxic effects, especially acute and long-term esophagitis and pneumonitis, of this regimen in these patients. III. Determine the response rate, duration to progression, and sites of relapse in patients treated with this regimen. PROTOCOL OUTLINE: This is a multicenter, dose-escalation study of irinotecan. Patients receive irinotecan IV over 90 minutes and cisplatin over 1 hour on day 1. Patients also undergo radiotherapy once daily on days 1-5. Treatment repeats every 7 days for 7 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 3-27 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC); Stage IIIB or bulky stage IIIA not amenable to surgical resection; Medically inoperable stage II or non-bulky stage IIIA; Locally recurrent disease following surgery that is not amenable to further surgical resection - No small cell carcinoma or mixed cytology - No disease beyond radiation portal (T4 tumors with documented multifocal malignant pleural involvement or extension of supraclavicular nodal disease to cervical chain) - No pleural effusion; Pleural effusions visible on CT scan but not on chest x-ray that are inaccessible to thoracentesis or are cytologically negative are allowed - Ineligible for enrollment on protocol RTOG 93-09 --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for NSCLC; No prior irinotecan or topotecan - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy for NSCLC; No prior radiotherapy to the chest - Surgery: See Disease Characteristics - Other: No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2; Karnofsky 50-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 2,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; No known Gilbert's disease - Renal: Creatinine no greater than 1.5 mg/dL; Calcium less than 12.0 mg/dL - Cardiovascular: No symptomatic cardiovascular disease; No active angina No congestive heart failure requiring active therapy; No uncontrolled arrhythmias; No myocardial infarction within the past 6 months - Pulmonary: FEV1 at least 1.0 L unless cleared by radiation oncologist - Other: Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception for 3 months before study, during study, and for 3 months after study; HIV negative; No other concurrent active or invasive malignancy except nonmelanoma skin cancer; Less than 10% unintended weight loss within 3 months of diagnosis; No other concurrent medical condition that would preclude study; No social situation or psychiatric disorder that would preclude study; No active or uncontrolled infection; No history of seizures; No uncontrolled diabetes mellitus (random blood sugar at least 250 mg/dL)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CoreyLanger, Study Chair, Fox Chase Cancer Center
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
United States
St. Francis Medical Center
Trenton, New Jersey, 08629
United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
United States
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, 07701
United States
Community Medical Center
Toms River, New Jersey, 08755
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
South Jersey Regional Cancer Center
Millville, New Jersey, 08332
United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
United States
Additional Information:
Study ID Numbers: CDR0000068803; FCCC-98020,NCI-G01-1995
Study Start Date: January 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022308
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
2. Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
4. Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
5. Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Drexel Hill Clinical Trials
Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
|
|
|
|
|
|
|
|
