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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
administered at a dose of 1100 mg/m\^2 by intravenous infusion over 1 hour and repeated every three weeks
administered intravenously prior to PET scan
Arizona Clinical Research Center, Incorporated
Tucson, Arizona, United States
Response Rate (Complete or Partial)
Time frame: From registration until disease progression/recurrence
Safety and Tolerability: the Number of Subjects Experiencing a Serious Adverse Events
The number of participants with at least one Serious Adverse Event was measured.
Time frame: 30 days following the last administration of study treatment
Survival
Time frame: Every 3 months for 2 years after discontinuation
Progression-free Survival
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 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
Time to Progression
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.
Time frame: From registration of the first subject until radiological progression or recurrence whichever came first
Pharmacokinetics
Time frame: Days 1 and 2 of Cycles 1 and 4
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