Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: non-small cell lung cancer chemotherapy figitumumab insulin-like growth 1 factor receptor IGF-IR monoclonal antibody
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 282
Healthy volunteers: no

Brief summary:
Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when administered with paclitaxel, carboplatin and erlotinib.

Phase 2: To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer

Detailed description:

Arms:
arm 1: CP-751,871 + paclitaxel + carboplatin arm 2: 1. Phase 1b Dose Escalation /Expansion: CP-751,871 + paclitaxel + carboplatin
2. Phase 1b Erlotinib Extension: CP-751,871 + paclitaxel + carboplatin + erlotinib

Interventions: intervention 1: CP-751,871 intervention 2: paclitaxel intervention 3: carboplatin intervention 4: CP-751,871 intervention 5: paclitaxel intervention 6: carboplatin intervention 7: erlotinib
Intervention descriptions: intervention 1: Phase 2 Arm A:

CP-751,871 20 mg/kg IV over 2.5 hours up to 17 cycles intervention 2: Phase 2 Arm A:

Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles

Phase 2 Arm B:

Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles intervention 3: Phase 2 Arm A:

Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles

Phase 2 Arm B:

Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles intervention 4: Phase 1b Dose Escalation/Expansion: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) Phase 1b Erlotinib Extension: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) intervention 5: Phase 1b Dose Escalation/Expansion: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) Phase 1b Erlotinib Extension: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) intervention 6: Phase 1b Dose Escalation/Expansion: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) Phase 1b Erlotinib Extension: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) intervention 7: Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles)

Protocol document: