Conditions: Extensive-Stage Small Cell Lung Cancer
Keywords: SCLC Amrubicin Carboplatin Pegfilgrastim Neulasta
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 81
Healthy volunteers: no

Brief summary:
This proposed trial will investigate the combination of amrubicin and carboplatin in the first-line treatment of patients with extensive-stage small cell lung cancer (ES- SCLC). Since myelosuppression is the most common toxicity produced by this drug combination, pegfilgrastim will be administered with each treatment cycle. This trial will be the first clinical trial to evaluate a combination of amrubicin and carboplatin in the first-line treatment of ES SCLC in a U.S. population.

Detailed description:

Arms:
arm 1: Systemic therapy

Interventions: intervention 1: Amrubicin intervention 2: Carboplatin intervention 3: Pegfilgrastim
Intervention descriptions: intervention 1: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle intervention 2: AUC=5 IV, Day 1 of each 3-week treatment cycle intervention 3: 6 mg SQ on Day 4 of each 3 week treatment cycle

Protocol document: