Lung Cancer Clinical Trial
Official title:
A Phase II, Multi-Center, Open-Label, Trial of PR104 in Treatment Naive and Sensitive-relapse 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).
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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