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Patients With Advanced Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by Abraxis BioScience Inc., June 2008
Sponsored by: Abraxis BioScience Inc.
Information provided by: Abraxis BioScience Inc.
ClinicalTrials.gov Identifier: NCT00540514
  Purpose

The purpose of this study is to compare disease response of ABI-007 plus Carboplatin vs Taxol and Carboplatin as first-line therapy in patients with advanced NSCLC


Condition Intervention Phase
Non-Small Cell Lung Carcinoma
Drug: ABI-007
Drug: Taxol
Phase III

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Phase III Trial of ABI-007 and Carboplatin Compared With Taxol and Carboplatin as First-Line Therapy in Patients With Advacned Non-Small Cell Lung Cancer (NSCLC)

Further study details as provided by Abraxis BioScience Inc.:

Primary Outcome Measures:
  • Response rate [ Time Frame: none specified ] [ Designated as safety issue: No ]

Estimated Enrollment: 1050
Study Start Date: November 2007
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
ABI-007 weekly
Drug: ABI-007
ABI-007 100mg/m2 weekly
2: Active Comparator
Taxol every 3 weeks
Drug: Taxol
Taxol 200mg/m2 q 3 weeks

  Eligibility

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

Inclusion Criteria:

  • Historically or cytologically confirmed stage IIIB or IV NSCLC
  • Male or non-pregnant and non-lactating female, and equal or greater than age 18
  • If a female patient is of child-bearing potential, as evidence by regular menstrual periods, she must have a negative serum pregnancy test (BhCG) documented within 72 hours of the first administration of study drug
  • If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator
  • No other current active malignancy
  • Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion
  • Patients must have received no prior chemotherapy for the treament of metastatic disease. Adjuvant chemotherapy permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study
  • Patient has the following blood counts at baseline
  • ANC greater or equal to 1.5x10^9/L
  • Platelets greater or equal to 100x10^9 g/dL
  • Hgb greater than equal to 9/dL
  • Patients has the following blood chemistry levels at baseline
  • AST (SGOT), ALT (SGPT) less than or equal to 2.5x upper limit of normal range (ULN)or less than or equal to 5.0x ULN if liver metastases;
  • total bilirubin less than or equal to ULN
  • creatine less than or equal to 1.5mg/dL
  • Expected survival of greater than 12 weeks
  • ECOG performance status 0 or 1
  • Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities

Exclusion Criteria:

  • Evidence of active brain metastases, including leptomeningeal involvment. Prior evidence of brain metastasis permitted only if stable 2 months after completion of treatment
  • The only evidence of disease is non-measurable
  • Patient has pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE).
  • Patient received radiotherapy in last 4 weeks, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed
  • Patient has a clinically significant concurrent illness
  • Patient has received treatment with any investigational drug within the previous 4 weeks
  • Patient has a history of allergy or hypersensitivity to any of the study drugs
  • Patient has serious medical risk factors involving any of the major systems such that the investigator considers it unsafe for the patient to receive an experimental research drug
  • Patient is enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540514

Contacts
Contact: Selena Rush 919-433-8465 srush@abraxisbio.com

  Show 25 Study Locations
Sponsors and Collaborators
Abraxis BioScience Inc.
  More Information

Responsible Party: Abraxis BioScience ( Dr. Jose Iglesias )
Study ID Numbers: CA031
Study First Received: October 4, 2007
Last Updated: July 11, 2008
ClinicalTrials.gov Identifier: NCT00540514  
Health Authority: United States: Food and Drug Administration

Keywords provided by Abraxis BioScience Inc.:
Advanced Non-Small Cell Lung Cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Carboplatin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009