A Phase II, Multi-Center, Open-Label, Trial of PR104 in Treatment Naive and Sensitive-relapse Small Cell Lung Cancer
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate (Complete or Partial)
From registration until disease progression/recurrence
United States: Food and Drug Administration
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Joliet Oncology-Hematology Associates, Limited - West||Joliet, Illinois 60435|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|James Graham Brown Cancer Center at University of Louisville||Louisville, Kentucky 40202|
|Front Range Cancer Specialists||Fort Collins, Colorado 80528|
|University of Florida Health Science Center - Jacksonville||Jacksonville, Florida 32209|
|Stanford Cancer Center||Stanford, California 94305-5824|
|Good Samaritan Hospital Cancer Treatment Center||Cincinnati, Ohio 45220|
|Arizona Clinical Research Center, Incorporated||Tucson, Arizona 85715|
|Tower Cancer Research Foundation||Beverly Hills, California 90211|
|Welborn Clinic||Evansville, Indiana 47714|
|Peninsula Cancer Institute - Newport News Office||Newport News, Virginia 23601|
|Kentuckiana Cancer Institute, PLLC||Louisville, Kentucky 40202|
|Gabrail Cancer Center - Canton Office||Canton, Ohio 44718|
|California Cancer Care, Incorporated - Greenbrae||Greenbrae, California 94904|
|Pacific Shores Medical Group - Long Beach||Long Beach, California 90813|
|Purchase Cancer Group - Paducah||Paducah, Kentucky 42001|
|Cancer and Blood Specialists of Nevada - Henderson||Henderson, Nevada 89074|