Conditions: Lung Cancer
Keywords: extensive stage small cell lung cancer limited stage small cell lung cancer recurrent small cell lung cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 5
Healthy volunteers: no

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.

Arms:
arm 1: PR104 will be administered once every 21 days by IV

Interventions: intervention 1: PR104 intervention 2: F-18-fluoromisonidazole
Intervention descriptions: intervention 1: administered at a dose of 1100 mg/m\^2 by intravenous infusion over 1 hour and repeated every three weeks intervention 2: administered intravenously prior to PET scan

Protocol document: