Clinical trial NCT00354562: A Phase 2 Study Evaluating ABT-751 in Combination With Taxotere in Advanced Non-Small Cell Lung Cancer
Official title: A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Non-Small Cell Lung Cancer
Keywords: Lung Cancer
Non-Small Cell Lung Cancer
NSCLC
ABT-751
docetaxel
Taxotere
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy of ABT-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic NSCLC.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free Survival
timeFrame: Subjects may remain on study until disease progression
Secondary outcomes:
measure: Overall Survival
timeFrame: Subject may remain on study until disease progression
measure: Response Rate
timeFrame: Subject may remain on study until disease progression
measure: Time-to-Progression (TTP)
timeFrame: Subject may remain on study until disease progression
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Ref # / Investigator 3572
state: Alabama
city: Burbank
country: United States
facility: Site Ref # / Investigator 4771
state: California
city: Orange
country: United States
facility: Site Ref # / Investigator 3574
state: California
city: Rancho Mirage
country: United States
facility: Site Ref # / Investigator 3567
state: California
city: Gurnee
country: United States
facility: Site Ref # / Investigator 3512
state: Illinois
city: Hackensack
country: United States
facility: Site Ref # / Investigator 3565
state: New Jersey
city: Buffalo
country: United States
facility: Site Ref # / Investigator 3569
state: New York
city: Cleveland
country: United States
facility: Site Ref # / Investigator 3511
state: Ohio
city: Ravenna
country: United States
facility: Site Ref # / Investigator 5237
state: Ohio
city: Crossville
country: United States
facility: Site Ref # / Investigator 3551
state: Tennessee
city: Knoxville
country: United States
facility: Site Ref # / Investigator 3549
state: Tennessee
city: Nashville
country: United States
facility: Site Ref # / Investigator 3571
state: Tennessee
city: Weston
country: United States
facility: Site Ref # / Investigator 3510
state: Wisconsin
city: Sydney
country: Canada
facility: Site Ref # / Investigator 3563
state: Nova Scotia
city: Barrie
country: Canada
facility: Site Ref # / Investigator 3559
state: Ontario
city: Sudbury
country: Canada
facility: Site Ref # / Investigator 3561
state: Ontario
city: Greenfield Park
country: Canada
facility: Site Ref # / Investigator 3560
state: Quebec
city: Montreal
country: Canada
facility: Site Ref # / Investigator 3562
state: Quebec
city: Montreal
country: Canada
facility: Site Ref # / Investigator 2222
state: Quebec
city: Regina
country: Canada
facility: Site Ref # / Investigator 3558
state: Saskatchewan
city: Cork
country: Ireland
facility: Site Ref # / Investigator 5097
city: Dublin 24
country: Ireland
facility: Site Ref # / Investigator 4986
city: Dublin 4
country: Ireland
facility: Site Ref # / Investigator 4999
city: Dublin 7
country: Ireland
facility: Site Ref # / Investigator 5158
city: Dublin 8
country: Ireland
facility: Site Ref # / Investigator 4971
city: Barming
country: United Kingdom
facility: Site Ref # / Investigator 5270
city: Belfast
country: United Kingdom
facility: Site Ref # / Investigator 5259
city: Edinburgh
country: United Kingdom
facility: Site Ref # / Investigator 5271
city: Glasgow
country: United Kingdom
facility: Site Ref # / Investigator 5017
city: Hull
country: United Kingdom
facility: Site Ref # / Investigator 5274
city: Surrey
country: United Kingdom
facility: Site Ref # / Investigator 5273
city: Surrey
country: United Kingdom
facility: Site Ref # / Investigator 5268
Study officials:
affiliation: Abbott
name: Helen Eliopoulos, MD
role: STUDY_DIRECTOR
References: