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Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Chemotherapy Plus 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 Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical research trials and Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer medical trials take place in many of places throughout 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer. Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer  Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,stage 3A non-small cell lung cancer
Status: Recruiting
Sponsor(s): Radiation Therapy 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose (MTD) of gemcitabine when administered with carboplatin and thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in patients with stage IIIA or IIIB non-small cell lung cancer. - Determine the MTD of gemcitabine and paclitaxel when administered with thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in these patients. OUTLINE: This is a multicenter, dose-escalation study of gemcitabine and paclitaxel. Patients are sequentially assigned to 1 of 3 treatment regimens. - Regimen A: Patients receive gemcitabine IV over 30-60 minutes on days 1, 8, 22, 29, and 43 and thoracic radiotherapy daily 5 days a week for 7 weeks beginning on day 1. - Regimen B (closed to accrual as of 5/13/03): Patients receive gemcitabine and thoracic radiotherapy as in regimen A and carboplatin IV over 30 minutes on days 1, 8, 22, 29, and 43. - Regimen C: Patients receive gemcitabine and thoracic radiotherapy as in regimen A and paclitaxel IV over 1 hour on days 1, 8, 22, 29, and 43. At 3 weeks after completion of chemoradiotherapy, all patients receive adjuvant gemcitabine IV over 30-60 minutes on days 71, 78, 92, and 99 and carboplatin IV over 30 minutes on days 71 and 92. The first 6 patients enrolled receive regimen A to determine the safety of the initial dose of gemcitabine. After completion of regimen A, cohorts of 3-6 patients receive escalating doses of gemcitabine in regimen B (closed to accrual as of 5/13/03) until the maximum tolerated dose (MTD) is determined. In a separate sequence, cohorts of 3-6 patients receive alternating escalating doses of gemcitabine and paclitaxel in regimen C until the MTD is determined. The MTD is defined as the dose preceding that at which at least 3 of 6 patients experience dose-limiting toxicity. Patients are followed at 3 months, 6 months, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 78 patients will be accrued for this study within 29 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed loco-regionally advanced non-small cell lung cancer meeting one of the following staging criteria: - Medically inoperable stage IIIA - Unresectable stage IIIA or IIIB - Measurable disease on three-dimensional planning CT scan - No post-resection intrathoracic tumor recurrence - No pleural effusion on chest x-ray except those occurring after attempted thoracotomy or other invasive thoracic procedure - No evidence of small cell histology - No evidence of hematogenous or distant metastases PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - Platelet count at least 100,000/mm^3 - Absolute granulocyte count at least 2,000/mm^3 - Hemoglobin at least 8.0 g/dL Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT no greater than 1.5 times upper limit of normal (unless caused by documented benign disease) Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No myocardial infarction within the past 6 months - No symptomatic heart disease, including angina, congestive heart failure, or uncontrolled arrhythmia Pulmonary: - FEV_1 greater than 1,000 mL Other: - No other invasive malignancy within the past 3 years except nonmelanoma skin cancer - No weight loss of more than 10% in 3 months prior to diagnosis - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior thoracic or neck radiotherapy Surgery: - See Disease Characteristics - No prior complete or subtotal tumor resection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HakChoy, Study Chair, Simmons Cancer Center
Monmouth Medical Center *Recruiting*
Long Branch, New Jersey, 07740-6395
United States
Recruiting Smitha Gollamudi 732-923-6890
Pocono Cancer Center *Recruiting*
East Stroudsburg, Pennsylvania, 18301
United States
Recruiting Michael Greenberg 570-476-3488
Dixie Regional Medical Center *Recruiting*
St. George, Utah, 84770
United States
Recruiting Ray Richards 801-688-4175
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Elizabeth Gore 414-805-4465
Cottonwood Hospital Medical Center *Recruiting*
Murray, Utah, 84107
United States
Recruiting Contact Person 801-314-5300
Mercy Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15219
United States
Recruiting Michael Dougherty 412-232-7862
Utah Valley Regional Medical Center - Provo *Recruiting*
Provo, Utah, 84604
United States
Recruiting Tarlton Blair 801-373-7850 ext. 2480
Wendt Regional Cancer Center of Finley Hospital *Recruiting*
Dubuque, Iowa, 52001
United States
Recruiting Thomas Lally 319-589-2468
Cancer Care Center, Incorporated *Recruiting*
Salem, Ohio, 44460
United States
Recruiting Contact Person 330-375-3557
McKay-Dee Hospital Center *Recruiting*
Ogden, Utah, 84403
United States
Recruiting Contact Person 801-408-2182
Delaware County Memorial Hospital *Recruiting*
Drexel Hill, Pennsylvania, 19026
United States
Recruiting Rachelle Lanciano 610-284-8240
University of Miami Sylvester Cancer Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Arnold Markoe 305-243-4319
Akron City Hospital *Recruiting*
Akron, Ohio, 44304
United States
Recruiting William Demas 330-375-3557
LDS Hospital *Recruiting*
Salt Lake City, Utah, 84143
United States
Recruiting William Sause 801-408-1146
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center *Recruiting*
La Crosse, Wisconsin, 54601
United States
Recruiting Philip Doescher 608-782-7300 ext. 2588
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-5671
United States
Recruiting A.J. Cmelak 615-322-2555
Veterans Affairs Medical Center - Milwaukee (Zablocki) *Recruiting*
Milwaukee, Wisconsin, 53295
United States
Recruiting Roger Byhardt 414-384-2000 ext. 2585
CCOP - Bay Area Tumor Institute *Recruiting*
Oakland, California, 94609-3305
United States
Recruiting Brenda Shank 510-456-8570
Danville Regional Medical Center *Recruiting*
Danville, Virginia, 24541
United States
Recruiting Contact Person 434-799-2100
Additional Information:
Study ID Numbers: CDR0000068622; RTOG-L-0017
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016315
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
2. Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
3. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors
4. Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
5. Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other Ohio Clinical Trials
Other Akron Clinical Trials
Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
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