Lung Cancer, Non-Small Cell Lung Cancer
Conditions
Keywords
Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, ABT-751, docetaxel, Taxotere
Brief summary
To determine the efficacy of ABT-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic NSCLC.
Interventions
DRUGABT-751
200mg ABT-751 daily for 14 days every 21 days
DRUGPlacebo
Placebo daily for 14 days every 21 days
DRUGDocetaxel
Standard Docetaxel every 21 days
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically documented NSCLC * Locally advanced (Stage III) or metastatic (Stage IV) NSCLC * Only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy) * Only one prior anti-tumor treatment regimen in the curative setting * Progressive disease following the previous anti-tumor treatment regimen * Measurable disease by RECIST criteria * Brain metastasis must be stable and well-controlled ECOG performance score 0-2All anti-tumor therapy discontinued at least 3 weeks prior to study entryAll adverse events from prior treatment are resolved or stableAdequate hematologic, renal, and hepatic functionFemales must not be pregnantWilling to take adequate measures to prevent pregnancyLife expectancy of at least 3 monthsAble to complete the Quality of Life questionnaireVoluntarily signed informed consent * Only one prior anti-tumor treatment regimen in the curative setting * Progressive disease following the previous anti-tumor treatment regimen * Measurable disease by RECIST criteria * Brain metastasis must be stable and well-controlled * ECOG performance score 0-2 * All anti-tumor therapy discontinued at least 3 weeks prior to study entry * All adverse events from prior treatment are resolved or stable * Adequate hematologic, renal, and hepatic function * Females must not be pregnant * Willing to take adequate measures to prevent pregnancy * Life expectancy of at least 3 months * Able to complete the Quality of Life questionnaire * Voluntarily signed informed consent
Exclusion criteria
* Greater that Grade 1 neurological findings * Allergy to sulfa medications * Previous treatment with ABT-751 or docetaxel * Receipt of more than one investigational agent for NSCLC * Significant weight loss (\>10%) within 6 weeks of study entry * Glucose-6-phosphate dehydrogenase deficiency or porphyria * Significant systemic disease that would adversely affect participation * Class 3-4 New York Heart Association classification status * Other cancers except in situ carcinoma of the cervix, basal or squamous cell skin cancer, or any other cancer considered adequately treated and cured by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival | Subjects may remain on study until disease progression |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | Subject may remain on study until disease progression |
| Response Rate | Subject may remain on study until disease progression |
| Time-to-Progression (TTP) | Subject may remain on study until disease progression |
Countries
Canada, Ireland, United Kingdom, United States
Outcome results
None listed