PR104 in Treating Patients With Previously Untreated or Relapsed Small Cell Lung Cancer
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Multi-Center, Open-Label, Trial of PR104 in Treatment Naive and Sensitive-relapse Small Cell Lung Cancer|
- Response Rate (Complete or Partial) [ Time Frame: From registration until disease progression/recurrence ] [ Designated as safety issue: No ]
- Safety and Tolerability: the Number of Subjects Experiencing a Serious Adverse Events [ Time Frame: 30 days following the last administration of study treatment ] [ Designated as safety issue: Yes ]The number of participants with at least one Serious Adverse Event was measured.
- Survival [ Time Frame: Every 3 months for 2 years after discontinuation ] [ Designated as safety issue: No ]
- Progression-free Survival [ Time Frame: Tumor measurements and assessments based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria were performed 6 weeks after first dose and as dictated by subject's malignancy ] [ Designated as safety issue: No ]Progression free survival (PFS) is the time (days) from date of registration to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented.
- Time to Progression [ Time Frame: From registration of the first subject until radiological progression or recurrence whichever came first ] [ Designated as safety issue: No ]Time to progression (TTP) was defined as the time from date of registration to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
- Pharmacokinetics [ Time Frame: Days 1 and 2 of Cycles 1 and 4 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||January 2009|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
PR104 will be administered once every 21 days by IV
administered at a dose of 1100 mg/m^2 by intravenous infusion over 1 hour and repeated every three weeks
Other Name: PR-104Other: F-18-fluoromisonidazole
administered intravenously prior to PET scan
Other Name: FMISO
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544674
|United States, Arizona|
|Arizona Clinical Research Center, Incorporated|
|Tucson, Arizona, United States, 85715|
|United States, California|
|Tower Cancer Research Foundation|
|Beverly Hills, California, United States, 90211|
|California Cancer Care, Incorporated - Greenbrae|
|Greenbrae, California, United States, 94904-2007|
|Pacific Shores Medical Group - Long Beach|
|Long Beach, California, United States, 90813|
|Stanford Cancer Center|
|Stanford, California, United States, 94305-5824|
|United States, Colorado|
|Front Range Cancer Specialists|
|Fort Collins, Colorado, United States, 80524-4038|
|United States, Florida|
|University of Florida Health Science Center - Jacksonville|
|Jacksonville, Florida, United States, 32209|
|United States, Illinois|
|Joliet Oncology-Hematology Associates, Limited - West|
|Joliet, Illinois, United States, 60435|
|United States, Indiana|
|Evansville, Indiana, United States, 47713|
|United States, Kentucky|
|James Graham Brown Cancer Center at University of Louisville|
|Louisville, Kentucky, United States, 40202|
|Kentuckiana Cancer Institute, PLLC|
|Louisville, Kentucky, United States, 40202|
|Purchase Cancer Group - Paducah|
|Paducah, Kentucky, United States, 42001|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|United States, Nevada|
|Cancer and Blood Specialists of Nevada - Henderson|
|Henderson, Nevada, United States, 89074|
|United States, Ohio|
|Gabrail Cancer Center - Canton Office|
|Canton, Ohio, United States, 44718|
|Charles M. Barrett Cancer Center at University Hospital|
|Cincinnati, Ohio, United States, 45219|
|Good Samaritan Hospital Cancer Treatment Center|
|Cincinnati, Ohio, United States, 45220|
|United States, Virginia|
|Peninsula Cancer Institute - Newport News Office|
|Newport News, Virginia, United States, 23601|