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Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery Clinical research trials and Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery healthcare trials happen in many 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 generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery. Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery  Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
For Condition: adenosquamous cell lung cancer,large cell lung cancer,stage 3A non-small cell lung cancer,adenocarcinoma of the lung,stage 3B non-small cell lung cancer,squamous cell lung cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI),National Center for Complementary and Alternative Medicine (NCCAM)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. AE-941 may help shrink or slow the growth of non-small cell lung cancer cells. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without AE-941 for non-small cell lung cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with or without AE-941 in treating patients who have stage III non-small cell lung cancer that cannot be removed by surgery.
Details: OBJECTIVES: - Determine the overall survival of patients with unresectable stage IIIA or IIIB non-small cell lung cancer treated with induction platinum-based chemotherapy and radiotherapy with or without Æ-941 (Neovastat). - Determine the progression-free survival, tumor response, tumor response duration, and metastasis-free survival of patients treated with these regimens. - Determine the tolerability of this regimen in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to stage (IIIA vs IIIB), type of platinum-based induction chemotherapy to be received (cisplatin and vinorelbine vs carboplatin and paclitaxel), and gender. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral Æ-941 (Neovastat) twice daily beginning on day 1 or within 10 days of initiation of chemotherapy. - Arm II: Patients receive oral placebo twice daily beginning on day 1 or within 10 days of initiation of chemotherapy. All patients receive induction chemotherapy with 1 of the following platinum-based regimens: - Cisplatin IV on days 1, 22, 50, and 71 and vinorelbine IV on days 1, 8, 22, 29, 50, 57, 71, and 78 - Carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on days 1, 22, 50, 57, 64, 71, 78, and 85 All patients receive radiotherapy beginning on day 50 for 6 weeks. Treatment in both arms continues in the absence of unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 756 patients (378 per treatment arm) will be accrued for this study within 36 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed newly diagnosed, untreated, unresectable stage IIIA or stage IIIB non-small cell lung cancer - Squamous cell carcinoma, adenocarcinoma, or large cell carcinoma of the lung - Mixed tumors allowed if non-small cell elements identified - Contralateral supraclavicular and/or scalene lymph node involvement allowed - No disease extending into the cervical region - At least 1 bidimensionally or unidimensionally measurable lesion - No pleural effusion unless cytologically negative or too small to safely aspirate - Not scheduled for curative cancer surgery PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 - Hematocrit greater than 30% Hepatic: - SGOT or SGPT less than 1.5 times upper limit of normal - Bilirubin normal Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Other: - No other major medical or psychiatric illness that would preclude study participation or consent - No medical condition that interferes with oral medication intake and/or absorption (gastrectomy or major intestinal resection) - No grade 2 or greater peripheral neuropathy unless secondary to mechanical etiology - No hypersensitivity to fish products - No more than 10% weight loss within past 3 months - No other malignancy within past 3 years except inactive carcinoma in situ of the cervix or nonmelanoma skin cancer - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 30 days since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics - Recovered from prior major surgery Other: - At least 30 days since prior shark cartilage products - No other concurrent investigational anticancer agents - No other concurrent cartilage products - No other concurrent investigational agents - No concurrent amifostine or other radioprotectants - No concurrent enrollment in other clinical trials
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesLu, Study Chair, M.D. Anderson Cancer Center
CCOP - Northwest *Recruiting*
Tacoma, Washington, 98405-0986
United States
Recruiting Lauren Colman 253-403-1461
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
Veterans Affairs Medical Center - Gainesville *Recruiting*
Gainesville, Florida, 32608-1197
United States
Recruiting Dean McCarley 352-374-6016
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting David Krause 269-373-7450
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K1H 1C4
Canada
Recruiting Susan Dent 613-737-7700 ext 5-6708
St. Agnes Cancer Center *Recruiting*
Baltimore, Maryland, 21229
United States
Recruiting William Waterfield 410-368-2909
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-241-6251
University of Texas Health Center at Tyler *Recruiting*
Tyler, Texas, 75708
United States
Recruiting Charles Haas 903-877-7830
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36688
United States
Recruiting Marcel Conrad 334-443-2233
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
Long Island Jewish Medical Center *Recruiting*
New Hyde Park, New York, 11040
United States
Recruiting Dilip Patel 718-470-8931
CancerCare Manitoba *Recruiting*
Winnipeg, Manitoba, R3E 0V9
Canada
Recruiting Catalin Mihalcioiu 204-787-1604
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
Cape Breton Cancer Centre *Recruiting*
Sydney, Nova Scotia, B1P 1P3
Canada
Recruiting Ron MacCormick 902-567-8080
Hartford Hospital *Recruiting*
Hartford, Connecticut, 06102-5037
United States
Recruiting Robert Siegel 860-249-6291
Mount Sinai Hospital - Toronto *Recruiting*
Toronto, Ontario, M5G 1X5
Canada
Recruiting Ronald Burkes 416-586-5117
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Charles Lu 713-792-6363
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Peter Kohler 616-391-1230
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
Jewish General Hospital - Montreal *Recruiting*
Montreal, Quebec, H3T 1E2
Canada
Recruiting Gerald Batist 514-340-8248
Hopital Charles Lemoyne *Recruiting*
Greenfield Park, Quebec, J4V 2H1
Canada
Recruiting Pierre Desjardins 450-466-5065
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus *Recruiting*
Seattle, Washington, 98122-4307
United States
Recruiting Gary Goodman 206-386-2122
MBCCOP - San Juan *Recruiting*
San Juan, , 00921-3201
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
Kingston Regional Cancer Centre *Recruiting*
Kingston, Ontario, K7L 5P9
Canada
Recruiting Richard Gregg 613-544-2630
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting Jeffrey Kirshner 315-472-7504
CCOP - Santa Rosa Memorial Hospital *Recruiting*
Santa Rosa, California, 95403
United States
Recruiting Leroy Keiser 707-521-3830
Indiana Community Cancer Care, Incorporated *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting William Dugan 317-924-4022
Complexe Hospitalier de la Sagamie *Recruiting*
Chicoutimi, Quebec, G7H 5H6
Canada
Recruiting Herve Simard 418-541-1000 ext 2092
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Abdul Dar 519-685-8650
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Northwestern Ontario Regional Cancer Care *Recruiting*
Thunder Bay, Ontario, P7B 6V4
Canada
Recruiting Dimitrios Vergidis 807-343-1610
Tom Baker Cancer Center - Calgary *Recruiting*
Calgary, Alberta, T2N 4N2
Canada
Recruiting Edna Rapp 403-670-1709
Arizona Clinical Research Center *Recruiting*
Tucson, Arizona, 85712
United States
Recruiting Steven Ketchel 602-324-2510
Royal Victoria Hospital - Montreal *Recruiting*
Montreal, Quebec, H3A 1A1
Canada
Recruiting Vera Hirsh 514-842-1231, x35997
Cancer Center at Lexington Clinic *Recruiting*
Lexington, Kentucky, 40504
United States
Recruiting Mark Sobczak 859-258-6505
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Michael Perry 573-882-4979
CHUS-Hopital Fleurimont *Recruiting*
Fleurimont, Quebec, J1H 5N4
Canada
Recruiting Marcel Rochon 819-346-1110 ext. 14816
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Paul Gilman 610-645-2057
University of Connecticut Cancer Center at University of Connecticut Health Center *Recruiting*
Hartford, Connecticut, 06105
United States
Recruiting Jonathan Sporn 860-714-4680
Memorial Medical Center *Recruiting*
Springfield, Illinois, 62781
United States
Recruiting Edward Braud 217-788-4959
Additional Information:
Study ID Numbers: CDR0000067853; MDA-ID-99303,NCI-T99-0046,NCCAM
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005838
Other Squamous Cell Lung Cancer Studies:
1. Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
2. Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
3. ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
4. Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
5. Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
Related Studies:
Other squamous cell lung cancer Clinical Trials
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Other Kansas City Clinical Trials
Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
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