Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Dec 2002
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 30, 2009
CompletedFirst Posted
Study publicly available on registry
December 2, 2009
CompletedApril 25, 2011
April 1, 2011
2.2 years
November 30, 2009
April 8, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
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
Each 49 day course of treatment until withdrawal or unacceptable toxicity
Safety: incidence and severity of adverse events, laboratory test abnormalities
Each 49 day course of treatment until withdrawal or unacceptable toxicity
Secondary Outcomes (1)
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]
Each 49 day course of treatment until withdrawal or unacceptable toxicity
Study Arms (1)
Paclitaxel
EXPERIMENTALInterventions
Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with serious, uncontrolled medical illness
- Patients with previous therapy with taxanes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 30, 2009
First Posted
December 2, 2009
Study Start
December 1, 2002
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
April 25, 2011
Record last verified: 2011-04