Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01024062
First received: November 30, 2009
Last updated: April 8, 2011
Last verified: April 2011

November 30, 2009
April 8, 2011
December 2002
March 2005   (final data collection date for primary outcome measure)
  • Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on "Response Evaluation Criteria in Solid Tumors (RECIST)" in patients with no prior chemotherapy [ Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity ] [ Designated as safety issue: No ]
  • Safety: incidence and severity of adverse events, laboratory test abnormalities [ Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01024062 on ClinicalTrials.gov Archive Site
Duration of response, [measured from the time that measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease is objectively documents] [ Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent non-small cell lung cancer

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Drug: Paclitaxel
Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent
Other Names:
  • Taxol
  • BMS-181339
Experimental: Paclitaxel
Intervention: Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2005
March 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with no prior chemotherapy who meet either of the listed below:
  • Patient with stage IIIB or IV disease
  • Patients with recurrent disease following potentially curative surgical resection
  • Patients with previous chemotherapy up to one regimen

Exclusion Criteria:

  • Patients with serious, uncontrolled medical illness
  • Patients with previous therapy with taxanes
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01024062
CA139-373
Yes
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP