Non-Small Cell Lung Cancer
Conditions
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
Interventions
DRUGPaclitaxel
Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed