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Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults



Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults

For Condition: Small Cell Lung Cancer
Status: No longer recruiting
Sponsor(s): Sponsor Name Pending ,
Synopsis: This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: (Patients must meet all of these criteria in order to be eligible to participate in this study.) - 1. Written informed consent (patient's written understanding of and agreement to participate in this study) - 2. At least 18 years old - 3. Patients with confirmed extensive small cell lung cancer (SCLC). - 4. No prior chemotherapy within 5 years of the diagnosis of SCLC. - 5. Presence of either measurable or non-measurable SCLC by X-ray or physical examination. - 6. At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient). - 7. At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting. - 8. Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function. EXCLUSION CRITERIA: (Patients cannot meet any of these criteria in order to be eligible to participate in this study.) - 1. Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids. - 2. Any active infection. - 3. Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk. - 4. Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC. - 5. Use of an investigational drug within 30 days before the first dose of study medication. - 6. Women who are pregnant or lactating. - 7. Patients of child-bearing potential who refuse to practice an adequate form of birth control. - 8. Patients with clinical evidence of any stomach or intestinal (GI) condition. - 9. Patients requiring treatment with the drug Cyclosporin A.
Total Enrollment: 

Location and Contact Information:

Study Site
Dallas,  Texas,  75237
United States
 

Study Site
Atlanta,  Georgia,  30322
United States
 

Study Site
Houston,  Texas,  77060
United States
 

Study Site
Montreal,  Quebec,  H2L 4M1
Canada
 

Study Site
Columbus,  Ohio,  43222
United States
 

Study Site
Porto Alegre,  ,  90035-003
Brazil
 

Study Site
Sault Sainte Marie,  Ontario,  P6B 1Y5
Canada
 

Study Site
Philadelphia,  Pennsylvania,  19140
United States
 

Study Site
Oshawa,  Ontario,  L1G 2B9
Canada
 

Study Site
Toronto,  Ontario,  M5G 2M9
Canada
 

Study Site
Albuquerque,  New Mexico,  87109
United States
 

Study Site
Belo Horizonte,  ,  30140-083
Brazil
 

Study Site
Weston,  Ontario,  M9N 1N8
Canada
 

Study Site
New Port Richey,  Florida,  34652
United States
 

Study Site
Houston,  Texas,  77029
United States
 

Study Site
Greenbrae,  California,  94904
United States
 

Study Site
Midland,  Texas,  79701-5946
United States
 

Study Site
McAllen,  Texas,  78503-1298
United States
 

Study Site
Chula Vista,  California,  91911
United States
 

Study Site
Albany,  New York,  12208
United States
 

Study Site
Caxias do Sul,  ,  95010-060
Brazil
 

Study Site
Dallas,  Texas,  75246
United States
 

Study Site
Wichita Falls,  Texas,  76310
United States
 

Study Site
Rancho Mirage,  California,  92270
United States
 

Study Site
Indianapolis,  Indiana,  46227
United States
 

Study Site
Ft. Worth,  Texas,  76104
United States
 

Study Site
Ocala,  Florida,  34474
United States
 

Study Site
Porto Alegre,  ,  90020-090
Brazil
 

Study Site
Birmingham,  Alabama,  35205
United States
 

Study Site
Pittsfield,  Massachusetts,  01201
United States
 

Study Site
Tegucigalpa,  , 
Honduras
 

Study Site
Ocala,  Florida,  34471
United States
 

Study Site
Minneapolis,  Minnesota,  55404
United States
 

Study Site
Longview,  Texas,  75601
United States
 

Study Site
Shreveport,  Louisiana,  71103
United States
 

Study Site
Greenfield Park,  Quebec,  J4V 2H1
Canada
 

Study Site
Vista,  California,  92083
United States
 

Study Site
Miami,  Florida,  33138
United States
 

Study Site
Edmonds,  Washington,  98026
United States
 

Study Site
Lauderhill,  Florida,  33319
United States
 

Study Site
Newmarket,  Ontario,  L3Y 2P9
Canada
 

Study Site
Augusta,  Georgia,  30912
United States
 

Study Site
Reno,  Nevada,  89502
United States
 

Study Site
Arlington,  Texas,  76012
United States
 

Study Site
Guadalajara,  ,  45170
Mexico
 

Study Site
El Paso,  Texas,  79915
United States
 

Study Site
Sherman,  Texas,  75090-0504
United States
 

Study Site
Kingston,  , 
Jamaica
 

Study Site
Fort Collins,  Colorado,  80524
United States
 

Study Site
Greenville,  South Carolina,  29615
United States
 

Study Site
Spokane,  Washington,  99218
United States
 

Study Site
Voorhees,  New Jersey,  08103
United States
 

Study Site
Tulsa,  Oklahoma,  74136-1902
United States
 

Study Site
Salvador,  ,  41920-000
Brazil
 

Study Site
Lewisville,  Texas,  75067
United States
 

Study Site
Tarpon Springs,  Florida,  34689
United States
 

Study Site
Chicago,  Illinois,  60612
United States
 

Study Site
Paris,  Texas,  75460
United States
 

Study Site
Austin,  Texas,  78745
United States
 

Study Site
Sainte-Foy,  Quebec,  G1V 4G5
Canada
 

Study Site
Phoenix,  Arizona,  85012
United States
 

Study Site
South Bend,  Indiana,  46601
United States
 

Study Site
Evansville,  Indiana,  47713
United States
 

Study Site
Aurora,  Illinois,  60506
United States
 

Study Site
Limerick,  Pennsylvania,  19468
United States
 

Study Site
Rio de Janeiro,  ,  20230-130
Brazil
 

Study Site
Albany,  New York,  12208
United States
 

Study Site
Chihuahua,  ,  31000
Mexico
 

Study Site
Bismark,  North Dakota,  58501
United States
 

Study Site
Columbia,  South Carolina,  29203
United States
 

Study Site
Tyler,  Texas,  75702
United States
 

Study Site
Denver,  Colorado,  80218
United States
 

Study Site
Winston Salem,  North Carolina,  27103
United States
 

Study Site
Lemoyne,  Pennsylvania,  17043
United States
 

Study Site
Guadalajara,  ,  44280
Mexico
 

Study Site
San Antonio,  Texas,  78205
United States
 

Study Site
Salem,  Virginia,  24153
United States
 

Study Site
St. Louis,  Missouri,  63141
United States
 

Study Site
Mesquite,  Texas,  75150
United States
 

Study Site
Asheville,  North Carolina,  28801
United States
 

Study Site
Soquel,  California,  95073
United States
 

Study Site
Rochester,  New York,  14623
United States
 

Study Site
Memphis,  Tennessee,  38104
United States
 

Study Site
Eugene,  Oregon,  97401
United States
 

Study Site
Fairfax,  Virginia,  22031
United States
 

Study Site
Poway,  California,  92064
United States
 

Study Site
Beaumont,  Texas,  77702-1449
United States
 

Study Site
Houston,  Texas,  77030
United States
 

Study Site
Webster,  Texas,  77598
United States
 

Study Site
Bismark,  North Dakota,  58501
United States
 

Study Site
Irving,  Texas,  75061-2244
United States
 

Study Site
Winnipeg,  Manitoba,  R3E 0V9
Canada
 

Study Site
Tucson,  Arizona,  85712
United States
 

Study Site
Peterborough,  Ontario,  K9H 7B6
Canada
 

Study Site
New York City,  New York,  10032
United States
 

Study Site
Orlando,  Florida,  32806
United States
 

Study Site
Bedford,  Texas,  76022
United States
 

Study Site
Mexico City,  ,  14000
Mexico
 

Study Site
Waco,  Texas,  76712
United States
 

Study Site
Cleveland,  Ohio,  44106-5065
United States
 

Study Site
Montreal,  Quebec,  H1T 2M4
Canada
 

Study Site
Pensacola,  Florida,  32501
United States
 

Study Site
Overland Park,  Kansas,  66210
United States
 

Study Site
Independence,  Missouri,  64055
United States
 

Study Site
Ft. Worth,  Texas,  76104
United States
 

Study Site
Westminster,  Maryland,  21157
United States
 

Study Site
Edmonton,  Alberta,  T6G 1E2
Canada
 

Study Site
Garland,  Texas,  75042-5788
United States
 

Study Site
Odessa,  Texas,  79761
United States
 

Study Site
Seattle,  Washington,  98133
United States
 

Study Site
San Diego,  California,  92102-8421
United States
 

Study Site
Valhalla,  New York,  10595
United States
 

Study Site
Chicago,  Illinois,  60637-1470
United States
 

Study Site
Dallas,  Texas,  75231
United States
 

Study Site
Sedona,  Arizona,  86336
United States
 

Study Site
Santiago,  , 
Chile
 

Study Site
Calgary,  Alberta,  T2N 4N2
Canada
 

Study Site
Norfolk,  Virginia,  23502
United States
 

Study Site
Panama,  , 
Panama
 

Study Site
Columbia,  Missouri,  65201
United States
 

Study Site
Fortaleza,  ,  60430-230
Brazil
 

Study Site
Washington D.C.,  District of Columbia,  20307-5001
United States
 

Study Site
Cary,  North Carolina,  27511
United States
 

Study Site
Thunder Bay,  Ontario,  P7A 7T1
Canada
 

Study Site
Dallas,  Texas,  75230-2510
United States
 

Study Site
Frederick,  Maryland,  21701
United States
 

Study Site
Santa Fe,  New Mexico,  87505
United States
 

Study Site
El Paso,  Texas,  79902
United States
 

Study Site
Morgantown,  West Virginia,  26506
United States
 

Study Site
Flagstaff,  Arizona,  86001
United States
 

Study Site
New Orleans,  Louisiana,  70112
United States
 

Study Site
Sydney,  Nova Scotia,  B1P 1P3
Canada
 

Study Site
New York City,  New York,  10021
United States
 

Study Site
Elk Grove Village,  Illinois,  60007
United States
 

Study Site
Oklahoma City,  Oklahoma,  73120-8347
United States
 

Study Site
Vancouver,  Washington,  98684
United States
 

Study Site
Ottawa,  Ontario,  K1H 1C4
Canada
 

Study Site
Atlanta,  Georgia,  30322
United States
 

Study Site
Sao Paulo,  ,  04023-062
Brazil
 

Study Site
Abilene,  Texas,  79601-2301
United States
 

Study Site
Montreal,  Quebec,  H3T 1E2
Canada
 

Study Site
San Jose,  , 
Costa Rica
 

Study Site
Hoover,  Alabama,  35216
United States
 

Study Site
Sao Paulo,  ,  05403-900
Brazil
 


Additional Information:
Study ID Numbers:
  104864-A/389; 
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043927

Other Small Cell Lung Cancer Studies:
1. INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer

2. The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC)

3. Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer

4. BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors

5. Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases

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