Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)
Phase 2
20 Years
74 Years
20 Years
74 Years
Not Enrolling
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Outcome Time Frame:
Each 49 day course of treatment until withdrawal or unacceptable toxicity
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CA139-373
NCT ID:
NCT01024062
Start Date:
December 2002
Completion Date:
March 2005
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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