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ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00071188
First received: October 14, 2003
Last updated: April 7, 2011
Last verified: April 2011
History of Changes
  Purpose

The purpose of the run-in phase of this study is to determine the appropriate and tolerable dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

The purpose of the randomized phase of this study is to determine the efficacy of ZD6474 alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
 Drug: ZD6474
Drug: Paclitaxel
Drug: Carboplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Study Start Date: February 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • 18 years or older
  • Histologically or cytologically confirmed locally advanced or metastatic NSCLC
  • No prior chemotherapy/biological therapy/radiation therapy
  • One or more measurable lesions
  • Life expectancy more than 12 weeks

Exclusion Criteria:

  • Brain metastases or spinal cord compression
  • Currently active skin disease
  • History of significant hemoptysis
  • Abnormal blood chemistry
  • Cardiac abnormalities
  • Recent significant cardiac event
  • Coexisting malignancies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00071188

  Show 34 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca ZD6474 Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00071188     History of Changes
Other Study ID Numbers: D4200C00007, D4200C00007(run-in), D4200C0007A (randomization)
Study First Received: October 14, 2003
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Non-Small-Cell Lung Carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
 Respiratory Tract Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 23, 2013