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

Conditions

• Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CP-751,871 — DRUG
  Phase 2 Arm A: CP-751,871 20 mg/kg IV over 2.5 hours up to 17 cycles
• paclitaxel — DRUG
  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
• carboplatin — DRUG
  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
• CP-751,871 — DRUG
  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)
• paclitaxel — DRUG
  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)
• carboplatin — DRUG
  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)
• erlotinib — DRUG
  Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles)

Study Details

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

Key Dates

First listed

Sep 7, 2005

Start date

Feb 28, 2005

Status verified

Oct 2013

Primary completion

Aug 31, 2011

Completion

Aug 31, 2011

Study Design

Enrollment

282 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b [ Time Frame: Start of treatment (baseline) up to the end of Cycle 1 (Day 21) ]

Locations (26)

Find similar trials in Tucson, AZ

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