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Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA 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 professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer Clinical research trials and Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer. Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer clinical trial. Human subjects often get the best healthcare possible for their Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer  Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
For Condition: stage 3A non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
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. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy. Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and paclitaxel, radiation therapy with gadolinium texaphyrin, and surgery in treating patients who have stage IIIA non-small cell lung cancer.
Details: OBJECTIVES: I. Determine and compare the frequency and grade of toxicities with the use of gadolinium texaphyrin as a radiosensitizer at two dose levels during preoperative radiotherapy in patients with stage IIIA non-small cell lung cancer. II. Measure the tumor, involved lymph nodes, and normal lung concentrations of gadolinium and compare to the image pixel intensity obtained by the 1.5 Tesla MRI in this patient population given this regimen. PROTOCOL OUTLINE: This is a dose escalation study of gadolinium texaphyrin (Gd-Tex). Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours every 3 weeks for 3 courses. Three weeks after completion of induction chemotherapy, patients receive Gd-Tex IV over 30 minutes twice weekly for 10 doses during preoperative radiotherapy. Radiotherapy is administered daily 5 days a week for 5 weeks. Approximately 3.5 weeks after completion of preoperative radiotherapy, patients undergo complete surgical resection. Three hours prior to surgery, patients receive an eleventh dose of Gd-Tex if they do not develop grade 3 or 4 toxicity with the tenth dose. Patients also receive a MRI without contrast prior to surgery. If the tumor is found to be unresectable, patients may receive additional radiation and/or chemotherapy. Cohorts of 3-6 patients receive escalating doses of Gd-Tex 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 toxicities. Patients are followed at 1 month and then every 4 months for 5 years. PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed non-small cell carcinoma of the lung Surgical staging with mediastinoscopy or anterior thoracotomy required - T1-T3, N2, M0 - Must appear resectable --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: No prior chest radiotherapy in area of tumor/nodes Surgery: Not specified Other: No other concurrent investigational agents --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: - WBC at least 3,000/mm3 - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin normal - AST no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 2 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia Pulmonary: FEV greater than 0.8 L Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Weight loss no greater than 10% of total body weight within past 3 months - No evidence of neuropathy - No history of allergy to platinum compounds, paclitaxel, porphyrins, or antiemetics appropriate for administration in conjunction with protocol chemotherapy - No concurrent uncontrolled illness (e.g., active infection) - No medical contraindication to MRI (e.g., pacemaker or aneurysm clip) - No G6PD deficiency - No known history of porphyria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnGrecula, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Additional Information:
Study ID Numbers: CDR0000067669; OSU-0003,NCI-T99-0073,OSU-99H0355,OSU-T99-0073
Study Start Date: January 2000
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005065
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer
2. Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
3. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors
4. Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors
5. Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
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