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Trial of Paclitaxel/Carboplatin + PF-3512676 vs Paclitaxel/Carboplatin Alone in Patients With Advanced Non-Small Cell Lung Cancer

NCT00254891 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 828

Last updated 2015-03-30

No results posted yet for this study

Summary

To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of paclitaxel

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

PF-3512676 + Paclitaxel + Carboplatin

* PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity. * Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. * Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.

DRUG

Paclitaxel + Carboplatin

* Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. * Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • Cyprus
  • Czechia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00254891 on ClinicalTrials.gov