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



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

For Condition: Small Cell Lung Cancer
Status: Recruiting
Sponsor(s): Sponsor Name Pending ,
Synopsis: This study will gather information on the effectiveness and safety of a treatment program for small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation therapy, and an oral investigational drug that may enhance the effects of radiation therapy. Study patients will receive two additional courses of the standard chemotherapy combination after completing radiation therapy.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: (A patient must meet all of these criteria in order to qualify for study participation.) - Patients must have newly diagnosed, limited stage SCLC (small cell lung cancer), with no prior radiotherapy. Patients are allowed to have had a resection or biopsy. - Women of reproductive potential must have a negative serum pregnancy test at the study screening visit. - Patients must give written informed consent to participate in the study. - Patients must be at least 18 years of age. - Patients must be able to take oral medication. - Patients should be completely recovered from recent surgery. - Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function. - Patients must be evaluated by the radiation oncologist prior to study entry. EXCLUSION CRITERIA: (A patient cannot meet any of these criteria in order to be eligible for study participation.) - Extensive Stage SCLC. - Women who are pregnant or lactating. - Use of an investigational drug within 30 days prior to the first dose of study medication. - Any medically/clinically significant active infection. - Symptoms of the SCLC spreading to the brain. - Patients with limited stage SCLC who have undergone complete resection with no measurable disease prior to starting chemotherapy. - Severe medical problems, unrelated to SCLC, that would limit the patient's full ability to follow all study rules and procedures, or that would expose the patient to extreme risk. - Other ongoing, immunotherapy or radiotherapy being administered at the time as study participation.
Total Enrollment: 

Location and Contact Information:

Study Site *Recruiting*
Akron,  Ohio,  44304
United States
Recruiting Study  Coordinator 330-375-4221

Study Site *Recruiting*
Green Bay,  Wisconsin,  54301-3508
United States
Recruiting Study  Coordinator 920-433-8889

Study Site *Recruiting*
San Antonio,  Texas,  78229-3900
United States
Recruiting Study  Coordinator 210-616-5638

Study Site *Terminated*
Cincinnati,  Ohio,  45219
United States
Terminated  

Study Site *Recruiting*
Los Angeles,  California,  90057
United States
Recruiting Study  Coordinator 213-989-1888

Study Site *Recruiting*
Phoenix,  Arizona,  85013
United States
Recruiting Study  Coordinator 602-274-4484

Study Site *Recruiting*
New Orleans,  Louisiana,  70112-2234
United States
Recruiting Study  Coordinator 504-568-6291

Study Site *Terminated*
Elk Grove Village,  Illinois,  60007
United States
Terminated  

Study Site *Terminated*
Columbus,  Ohio,  43222
United States
Terminated  

Study Site *Recruiting*
Scarborough,  Maine,  04074
United States
Recruiting Study  Coordinator 207-885-7634

Study Site *Recruiting*
Springfield,  Massachusetts,  01107
United States
Recruiting Study  Coordinator 413-794-3736

Study Site *Recruiting*
Cincinnati,  Ohio,  45219
United States
Recruiting Study  Coordinator 513-751-4448

Study Site *Recruiting*
Robbinsdale,  Minnesota,  55422
United States
Recruiting Study  Coordinator 763-520-5847

Study Site *No longer recruiting*
Charlotte,  North Carolina,  28204
United States
No longer recruiting  

Study Site *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting Study  Coordinator 612-624-5949

Study Site *Not yet recruiting*
Miami,  Florida,  33136
United States
Not yet recruiting Study  Coordinator 305-243-4180

Study Site *Terminated*
Cleveland,  Ohio,  44195
United States
Terminated  

Study Site *No longer recruiting*
Ft. Worth,  Texas,  76104
United States
No longer recruiting  

Study Site *Terminated*
Bethlehem,  Pennsylvania,  19017
United States
Terminated  

Study Site *Terminated*
LaJolla,  California,  92037
United States
Terminated  

Study Site *Recruiting*
New Orleans,  Louisiana,  70121
United States
Recruiting Study  Coordinator 504-842-4483

Study Site *Recruiting*
Lexington,  Kentucky,  40536
United States
Recruiting Study  Coordinator 859-257-3379

Study Site *Recruiting*
Madison,  Wisconsin,  53792
United States
Recruiting Study  Coordinator 608-262-8158

Study Site *Recruiting*
Gainesville,  Florida,  32610-0383
United States
Recruiting Study  Coordinator 352-265-0680

Study Site *Recruiting*
St. Louis,  Missouri,  63141
United States
Recruiting Study  Coordinator 314-523-5599

Study Site *Recruiting*
Indianapolis,  Indiana,  46260
United States
Recruiting Study  Coordinator 317-415-6631

Study Site *Recruiting*
La Crosse,  Wisconsin,  54601-5494
United States
Recruiting Study  Coordinator 608-775-2837

Study Site *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Study  Coordinator 501-686-8274

Study Site *Recruiting*
Fountain Valley,  California,  92882
United States
Recruiting Study  Coordinator 714-210-2300

Study Site *Not yet recruiting*
Keene,  New Hampshire,  03431
United States
Not yet recruiting Study  Coordinator 603-354-5467

Study Site *Not yet recruiting*
Charlottesville,  Virginia,  22908
United States
Not yet recruiting Study  Coordinator 434-924-5226

Study Site *Terminated*
Tucson,  Arizona,  85723
United States
Terminated  

Study Site *Terminated*
Houston,  Texas,  77030
United States
Terminated  

Study Site *Recruiting*
Duluth,  Minnesota,  55805
United States
Recruiting Study  Coordinator 218-249-5337

Study Site *Recruiting*
Bakersfield,  California,  93309
United States
Recruiting Study  Coordinator 661-862-7178

Study Site *Terminated*
Columbia,  Missouri,  65203
United States
Terminated  

Study Site *Recruiting*
Greensboro,  North Carolina,  27403-1199
United States
Recruiting Study  Coordinator 336-832-0824

Study Site *Recruiting*
Wausau,  Wisconsin,  54401
United States
Recruiting Study  Coordinator 715-847-2353

Study Site *Recruiting*
Shreveport,  Louisiana,  71103
United States
Recruiting Study  Coordinator 318-212-8088

Study Site *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting Study  Coordinator 216-844-1637

Study Site *Recruiting*
Toledo,  Ohio,  43614
United States
Recruiting Study  Coordinator 419-383-6583

Study Site *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Study  Coordinator 314-747-1849

Study Site *Recruiting*
Albuquerque,  New Mexico,  87109
United States
Recruiting Study  Coordinator 505-243-4039

Study Site *Recruiting*
Milwaukee,  Wisconsin,  53215
United States
Recruiting Study  Coordinator 414-649-6093


Additional Information:
Study ID Numbers:
  104864/535; 
Study Start Date: 
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043862

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