Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01024062
First received: November 30, 2009
Last updated: April 8, 2011
Last verified: April 2011
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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:
|
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 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 May 21, 2013