Combination Study Of CP-751,871 With Paclitaxel And Carboplatin In Advanced Lung Cancer

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

• Drug: CP-751,871
  

  Phase 2 Arm A:

  CP?751,871 20 mg/kg IV over 2.5 hours up to 17 cycles

• Drug: paclitaxel
  

  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

• Drug: carboplatin
  

  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

• Drug: CP-751,871
  
  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)
• Drug: paclitaxel
  
  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)
• Drug: carboplatin
  
  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)
• Drug: erlotinib
  
  Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles)

• Experimental: Phase 2 (Arms A & B)
  
  CP-751,871 + paclitaxel + carboplatin
  Interventions:
  

  • Drug: CP-751,871
  • Drug: paclitaxel
  • Drug: carboplatin
• Experimental: Phase 1b
  
  1. Phase 1b Dose Escalation /Expansion: CP-751,871 + paclitaxel + carboplatin
  2. Phase 1b Erlotinib Extension: CP-751,871 + paclitaxel + carboplatin + erlotinib
  Interventions:
  

  • Drug: CP-751,871
  • Drug: paclitaxel
  • Drug: carboplatin
  • Drug: erlotinib

Inclusion Criteria:

• Diagnosis of advanced/metastatic lung cancer

Exclusion Criteria:

• Previous treatment with chemotherapy
• Uncontrolled diabetes
• History/active cardiovascular disease