Clinical trial NCT00716534: Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Official title: A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of Carboplatin/Paclitaxel in Combination With ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced or Metastatic Non-Small Cell Lung Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2008-07-16
Enrollment: 145
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: This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC.


Eligibility criteria: Inclusion Criteria:

* Subject must be at least 18 years of age.
* Subject must have cytologically or histologically confirmed non-squamous NSCLC
* Subject must have recurrent or advanced (Stage IIIb with pleural or pericardial effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent.
* Subject has measurable disease, defined as at least 1 unidimensional measurable lesion on a computed tomography (CT) scan as defined by RECIST (for subjects in the randomized portion only).
* Subject has an ECOG Performance Score of 0-1.
* Willing to take adequate measures to prevent pregnancy.

Exclusion Criteria:

* The subject has NSCLC with a predominant squamous cell histology
* Subject has hypersensitivity to paclitaxel.
* Subject has received any anti-cancer therapy for treatment of NSCLC.
* Subject has received radiation therapy within 21 days of Study Day 1.
* Subject has had major surgery within 21 days.
* Subject has untreated brain or meningeal metastases.
* Subject is receiving therapeutic anticoagulation therapy.
* Subject has a central thoracic tumor lesion as defined by location within the hilar structures.
* Subject has proteinuria CTC Grade \> 1 at baseline.
* Subject has a history of, or currently exhibits clinically significant cancer related events of bleeding.
* The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) \> 90 mm Hg or systolic BP \> 140 mm Hg.
* The subject has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA) within 6 months of Study Day 1.
* The subject has a documented left ventricular (LV) ejection fraction \< 50%.
* The subject has known autoimmune disease with renal involvement (i.e., lupus).
* The subject is receiving combination anti-retroviral therapy for HIV.
* The subject has clinically significant uncontrolled condition(s).
* The subject has a history of another active cancer within the past 5 years.
* The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption.
* The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.
* The subject is pregnant or breast feeding.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Disease Progression
Secondary outcomes:
measure: Overall survival, best response rate, time to tumor progression, objective response rate, best percent change in tumor size, duration of response
timeFrame: Disease Progression
measure: Survival Rate
timeFrame: 12 Months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Site Reference ID/Investigator# 15850
state: Arizona
city: Peoria
country: United States
facility: Site Reference ID/Investigator# 15846
state: Arizona
city: Miami
country: United States
facility: Site Reference ID/Investigator# 15841
state: Florida
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 7179
state: Georgia
city: Lansing
country: United States
facility: Site Reference ID/Investigator# 15851
state: Michigan
city: Lebanon
country: United States
facility: Site Reference ID/Investigator# 15844
state: New Hampshire
city: Hackensack
country: United States
facility: Site Reference ID/Investigator# 22443
state: New Jersey
city: Greensboro
country: United States
facility: Site Reference ID/Investigator# 15848
state: North Carolina
city: Canton
country: United States
facility: Site Reference ID/Investigator# 22444
state: Ohio
city: Cleveland
country: United States
facility: Site Reference ID/Investigator# 15847
state: Ohio
city: Hershey
country: United States
facility: Site Reference ID/Investigator# 26842
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 13101
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 24122
state: Pennsylvania
city: Bedford Park
country: Australia
facility: Site Reference ID/Investigator# 19042
city: Cairns
country: Australia
facility: Site Reference ID/Investigator# 23682
city: Lismore
country: Australia
facility: Site Reference ID/Investigator# 21862
city: Woodville South
country: Australia
facility: Site Reference ID/Investigator# 19043
city: Jau
country: Brazil
facility: Site Reference ID/Investigator# 17703
city: Porto Alegre
country: Brazil
facility: Site Reference ID/Investigator# 23522
city: Porto Alegre
country: Brazil
facility: Site Reference ID/Investigator# 15601
city: Rio de Janeiro
country: Brazil
facility: Site Reference ID/Investigator# 17704
city: Santo Andre
country: Brazil
facility: Site Reference ID/Investigator# 22684
city: Sao Paulo
country: Brazil
facility: Site Reference ID/Investigator# 17702
city: Sao Paulo
country: Brazil
facility: Site Reference ID/Investigator# 23582
city: Kyjov
country: Czech Republic
facility: Site Reference ID/Investigator# 18964
city: Nachod
country: Czech Republic
facility: Site Reference ID/Investigator# 22504
city: Olomouc
country: Czech Republic
facility: Site Reference ID/Investigator# 18963
city: Prague 2
country: Czech Republic
facility: Site Reference ID/Investigator# 18962
city: Pribram V
country: Czech Republic
facility: Site Reference ID/Investigator# 19022
city: Kazan
country: Russian Federation
facility: Site Reference ID/Investigator# 38003
city: Kirov
country: Russian Federation
facility: Site Reference ID/Investigator# 38260
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 18064
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 18065
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 23312
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 18066
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 23562
city: Singapore
country: Singapore
facility: Site Reference ID/Investigator# 18961
Study officials:
affiliation: AbbVie
name: Justin L. Ricker, MD
role: STUDY_DIRECTOR
References:
citation: Ramalingam SS, Shtivelband M, Soo RA, Barrios CH, Makhson A, Segalla JG, Pittman KB, Kolman P, Pereira JR, Srkalovic G, Belani CP, Axelrod R, Owonikoko TK, Qin Q, Qian J, McKeegan EM, Devanarayan V, McKee MD, Ricker JL, Carlson DM, Gorbunova VA. Randomized phase II study of carboplatin and paclitaxel with either linifanib or placebo for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2015 Feb 10;33(5):433-41. doi: 10.1200/JCO.2014.55.7173. Epub 2015 Jan 5.