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
  Purpose

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


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: December 2002
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel 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

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024062

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01024062     History of Changes
Other Study ID Numbers: CA139-373
Study First Received: November 30, 2009
Last Updated: April 8, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on April 23, 2014