A Study of Cetuximab and Bevacizumab in Combination With Paclitaxel and Carboplatin in Stage IIIb/IV NSCLC

Conditions

• Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cetuximab — BIOLOGICAL
  Administered intravenously
• Bevacizumab — BIOLOGICAL
  Administered intravenously
• Paclitaxel — DRUG
  Administered intravenously
• Carboplatin — DRUG
  Administered intravenously

Study Details

The primary objective of this study will be to determine the progression free survival of patients with stage IIIb/IV non-small cell lung cancer (NSCLC) treated with dual agent monoclonal antibody therapy consisting of cetuximab and bevacizumab in combination with two different regimens of paclitaxel and carboplatin chemotherapy.

Key Dates

First listed

Jun 22, 2006

Start date

Dec 31, 2006

Status verified

May 2011

Primary completion

May 31, 2010

Completion

Dec 31, 2010

Study Design

Enrollment

121 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)
  Cycles 1-6: * Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week * Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle * Paclitaxel 200 mg/m² on day 1 of every 3 week cycle * Carboplatin area under curve (AUC=6 min\*mg/mL) on day 1 of every 3 week cycle Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met
• Active Comparator: Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)
  Cycles 1-6: * Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week * Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle Cycles 1-3: * Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles * Carboplatin AUC=6 min\*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Randomization to PD or date of death from any cause up to 33.1 months ]

Locations (43)

Find similar trials in Decatur, AL

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