Spots Global Cancer Trial Database for PR104 in Treating Patients With Previously Untreated or Relapsed Small Cell Lung Cancer
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Trial Identification
Brief Title: PR104 in Treating Patients With Previously Untreated or Relapsed Small Cell Lung Cancer
Official Title: A Phase II, Multi-Center, Open-Label, Trial of PR104 in Treatment Naive and Sensitive-relapse Small Cell Lung Cancer
Study ID: NCT00544674
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well PR-104 works in treating patients with previously untreated or relapsed small cell lung cancer (SCLC).
Detailed Description: OBJECTIVES: Primary * Estimate the response rate of PR-104 in patients with treatment-naive or sensitive-relapse small cell lung cancer. * Evaluate safety of this drug in these patients. Secondary * Evaluate survival of these patients. * Evaluate progression-free survival of these patients. * Evaluate time to progression in these patients. * Assess the pharmacokinetics (PK) of PR-104 and its alcohol metabolite. * Estimate the rate of hypoxia using 18F-fluoromisonidazole (FMISO) positron emission topography (PET) imaging. * Collect plasma samples for assessment of potential biomarkers of tumor hypoxia. OUTLINE: This is a multicenter study. Patients are stratified according to disease type (treatment-naive vs sensitive-relapse). Patients receive PR-104 intravenously (IV) over 1 hour on day 1. Treatment repeats every 21 days for up to 4 courses (for treatment-naive patients) or in the absence of disease progression or unacceptable toxicity (for sensitive-relapse patients). PK studies are performed during course 1 and after course 3. Blood is collected at baseline, during course 1, and at study completion for biomarker studies of tumor hypoxia (plasma proteins). Patients also undergo FMISO PET and fludeoxyglucose F18 (FDG) PET scans at baseline and after the second course of study therapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Clinical Research Center, Incorporated, Tucson, Arizona, United States
Tower Cancer Research Foundation, Beverly Hills, California, United States
California Cancer Care, Incorporated - Greenbrae, Greenbrae, California, United States
Pacific Shores Medical Group - Long Beach, Long Beach, California, United States
Stanford Cancer Center, Stanford, California, United States
Front Range Cancer Specialists, Fort Collins, Colorado, United States
University of Florida Health Science Center - Jacksonville, Jacksonville, Florida, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States
Welborn Clinic, Evansville, Indiana, United States
James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, United States
Kentuckiana Cancer Institute, PLLC, Louisville, Kentucky, United States
Purchase Cancer Group - Paducah, Paducah, Kentucky, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Cancer and Blood Specialists of Nevada - Henderson, Henderson, Nevada, United States
Gabrail Cancer Center - Canton Office, Canton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Good Samaritan Hospital Cancer Treatment Center, Cincinnati, Ohio, United States
Peninsula Cancer Institute - Newport News Office, Newport News, Virginia, United States
Contact Details
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