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Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III 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 and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III 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 With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer Clinical research trials and Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III 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 and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer. Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III 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 and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III 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 and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer  Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer
Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer
For Condition: squamous cell lung cancer,stage 3B non-small cell lung cancer,adenocarcinoma of the lung,stage 3A non-small cell lung cancer,large cell lung cancer
Status: No longer recruiting
Sponsor(s): Allos Therapeutics ,
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 efaproxiral may make the tumor cells more sensitive to radiation therapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without efaproxiral in treating non-small cell lung cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of chemotherapy combined with radiation therapy with or without efaproxiral in treating patients who have stage III non-small cell lung cancer.
Details: OBJECTIVES: - Compare the overall survival of patients with stage IIIA or IIIB non-small cell lung cancer treated with induction chemotherapy followed by radiotherapy with or without efaproxiral. - Compare time to progression, response rate, and pattern of failure of patients treated with these regimens. - Determine the safety of efaproxiral in these patients. - Determine the pharmacokinetics of efaproxiral in these patients. - Compare quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to chemotherapy regimen, Karnofsky performance status (70-80% vs 90-100%), and disease stage (IIIA vs IIIB). - Patients receive 1 of the following induction chemotherapy regimens: - Paclitaxel and carboplatin: Patients receive paclitaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for a total of 2 courses. - Cisplatin and gemcitabine: Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses. - Cisplatin and vinorelbine: Patients receive cisplatin IV on day 1 and vinorelbine IV on days 1, 8, and either 15 or 22. Treatment repeats every 28 days for a total of 2 courses. - Within 42 days after completion of chemotherapy, patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive efaproxiral IV over 30-45 minutes with supplemental oxygen and then undergo concurrent radiotherapy 5 days a week for 7 weeks. - Arm II: Patients receive supplemental oxygen and undergo radiotherapy as in arm I. Quality of life is assessed at baseline, on days 1 and 16 of radiotherapy, monthly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. Patients are followed monthly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 659 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed locally advanced, unresectable non-small cell lung cancer of 1 of the following subtypes: - Adenocarcinoma - Squamous cell carcinoma - Large cell carcinoma - Poorly differentiated carcinoma - Stage IIIA or IIIB - T1 or T2, N2 - T3, N1 or N2 - T4, any N - Any T, N3 - Histological or cytological confirmation of at least 1 positive lymph node required if the largest mediastinal node that is the basis of stage III disease is less than 2.0 cm in diameter - Clinically or radiologically measurable disease of at least 2.0 cm - Partially resected stage IIIB disease allowed provided a measurable lesion remains - No pleural effusion that is bloody, cytologically positive, or re-accumulated after thoracentesis - No metastatic disease by CT scan or MRI PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - Hemoglobin at least 10 g/dL - WBC at least 3,000/mm^3 - Absolute granulocyte count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - No clinically active congestive heart failure - No unstable angina - No severe arrhythmia by ECG Pulmonary - FVC and FEV_1 at least 50% of normal - Resting oxygen saturation by pulse oximetry (SpO_2) at least 90% on room air - Exercise SpO_2 at least 90% on room air Other - Not pregnant or nursing - Negative pregnancy test - Fertile female patients must use effective contraception during and for 30 days after study therapy - Male patients must use effective contraception during and for 90 days after study therapy - No loss of more than 10% of body weight within the past 3 months - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No significantly altered mental status or dementia that would preclude giving informed consent - No active infection - No other serious underlying medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - More than 28 days since prior biologic therapy - No concurrent colony-stimulating factors (randomized phase only) - No biologic therapy during and for 1 month after study therapy - No immune response modifiers during and for 1 month after study therapy Chemotherapy - No prior systemic chemotherapy Endocrine therapy - No hormonal therapy during and for 1 month after study therapy Radiotherapy - No prior thoracic radiotherapy Surgery - See Disease Characteristics - No prior total surgical resection Other - More than 28 days since prior investigational drugs or devices - No prior efaproxiral - No other cytotoxic therapy during and for 1 month after study therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HakChoy, Study Chair, Simmons Cancer Center
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Rambam Medical Center
Haifa, , 31096
Israel
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Schiffler Cancer Center
Wheeling, West Virginia, 26003
United States
North Idaho Cancer Center
Coeur D Alene, Idaho, 83814
United States
Willis - Knighton Cancer Center
Shreveport, Louisiana, 71103-3951
United States
Cancer Center at Lexington Clinic
Lexington, Kentucky, 40504
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
Providence Everett Medical Center - Pacific Campus
Everett, Washington, 98206
United States
Soroka University Medical Center
Beer-Sheva, , 84101
Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , 64239
Israel
Algemeen Ziekenhuis Middelheim
Antwerp, , 2020
Belgium
Hopital Notre- Dame du CHUM
Montreal, Quebec, H2L 4M1
Canada
Sheba Medical Center
Tel Hashomer, , 52621
Israel
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, G1R 2J6
Canada
St. Agnes Cancer Center
Baltimore, Maryland, 21229
United States
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
United States
Additional Information:
Study ID Numbers: CDR0000271438; ALLOS-RSR13RT-013ELITE
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055887
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
2. Chemotherapy, Tirapazamine, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
3. Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
4. Positron Emission Tomography for Detecting Non-small Cell Lung Cancer
5. Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other Clinical Trials
Other Haifa Clinical Trials
Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer
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