Clinical trial NCT00707889: Phase 2 Study of ABT-869 in Combination With mFOLFOX6 Versus Bevacizumab in Combination With mFOLFOX6 to Treat Advanced Colorectal Cancer
Official title: An Open-Label, Randomized Phase 2 Study of ABT-869 in Combination With mFOLFOX6 (Oxaliplatin, 5-Fluorouracil, and Folinic Acid) Versus Bevacizumab in Combination With mFOLFOX6 as Second-line Treatment of Subjects With Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Colorectal Cancer
Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2008-07-01
Enrollment: 159
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 effect of ABT-869 plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 on disease progression in advanced colorectal cancer.


Eligibility criteria: Inclusion Criteria:

Subject must be \>/= 18 years of age. Subject (male or female) must be diagnosed with adenocarcinoma of the colon or rectum. Subject must have metastatic disease or locally recurrent disease that is not amenable to surgical resection with curative intent.

Subject must have received one prior chemotherapy regimen containing irinotecan or a fluoropyrimidine for locally recurrent or metastatic colon or rectal cancer.

Subject has experienced progressive disease during or following the previous anti-tumor treatment.

Subject may have received prior adjuvant treatment for colorectal cancer. Subject has measurable disease by RECIST criteria (randomized portion only). Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1. Subject must have adequate bone marrow, renal and hepatic function. Subject must have Partial Thromboplastin Time (PTT) \< 1.5 x Upper Limit of Normal (ULN) and International Normalized Ratio (INR) \< 1.5.

Exclusion Criteria:

Subject has received more than one prior therapy in the metastatic setting. Lead-in Cohort only: The subject may have received more than one prior therapy in the metastatic setting.

Subject has received cytotoxic chemotherapy within 21 days prior to Study Day 1.

Subject has received non-cytotoxic, anti-cancer therapy within 21 days or within a period defined by 5 half lives whichever is shorter, prior to Study Day 1.

Subject has not recovered to less than or equal to Grade 1 clinically significant adverse effects/toxicities of the previous therapy.

Subject has received prior treatment with a tyrosine kinase inhibitor targeting VEGF or PDGF.

Subject has received prior treatment with oxaliplatin in the metastatic setting. Lead-in cohort only: Prior treatment with oxaliplatin will be allowed provided that any neuropathy as a result of the oxaliplatin treatment has resolved to less than or equal to Grade 1.

Subject has had major surgery within 28 days of Study Day 1. Subject has had radiotherapy within 14 days of Study Day 1. Subject has a history of hypersensitivity to recombinant murine monoclonal antibodies, oxaliplatin or other platinum-containing compounds, fluorouracil, or folinic acid.

Subject has a known intolerance to bevacizumab. Subject has untreated brain or meningeal metastases. Subject is receiving therapeutic anticoagulation therapy . Subject has a history of/or currently exhibits clinically significant cancer related events of bleeding.

Subject currently exhibits symptomatic or persistent, uncontrolled hypertension.

Subject has a history of myocardial infarction, stroke, or transient ischemic attack within six months of Study Day 1.

History of another active cancer within the past 5 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous cell or basal cell carcinoma of the skin.

Primary outcomes:
measure: Progression-free survival
timeFrame: Radiographic evaluation every 2 months, clinial evaluation every 2 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: from randomization until patient death or alive at 5 years
measure: 12-month overall survival rate
timeFrame: from randomization until patient death or alive at 5 years
measure: Objective response rate
timeFrame: from randomization until patient death or alive at 5 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Site Reference ID/Investigator# 11341
state: North Carolina
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 20801
state: Pennsylvania
city: Nashville
country: United States
facility: Site Reference ID/Investigator# 8360
state: Tennessee
city: Bedford Park
country: Australia
facility: Site Reference ID/Investigator# 18581
city: Herston
country: Australia
facility: Site Reference ID/Investigator# 23443
city: Bonheiden
country: Belgium
facility: Site Reference ID/Investigator# 18023
city: Brussels
country: Belgium
facility: Site Reference ID/Investigator# 23646
city: Leuven
country: Belgium
facility: Site Reference ID/Investigator# 18026
city: Roeselare
country: Belgium
facility: Site Reference ID/Investigator# 18022
city: Jau
country: Brazil
facility: Site Reference ID/Investigator# 26662
city: Porto Alegre
country: Brazil
facility: Site Reference ID/Investigator# 24245
city: Barrie
country: Canada
facility: Site Reference ID/Investigator# 23265
city: Edmonton
country: Canada
facility: Site Reference ID/Investigator# 21083
city: Ottawa
country: Canada
facility: Site Reference ID/Investigator# 22465
city: Nachod
country: Czech Republic
facility: Site Reference ID/Investigator# 22141
city: Heraklion
country: Greece
facility: Site Reference ID/Investigator# 22289
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 22286
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 22287
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 18281
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 18283
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 18282
city: Wellington South
country: New Zealand
facility: Site Reference ID/Investigator# 20281
city: Olsztyn
country: Poland
facility: Site Reference ID/Investigator# 20141
city: Warsaw
country: Poland
facility: Site Reference ID/Investigator# 17946
city: Warsaw
country: Poland
facility: Site Reference ID/Investigator# 38284
city: Aveiro
country: Portugal
facility: Site Reference ID/Investigator# 23908
city: Coimbra
country: Portugal
facility: Site Reference ID/Investigator# 22324
city: Faro
country: Portugal
facility: Site Reference ID/Investigator# 23724
city: Lisbon
country: Portugal
facility: Site Reference ID/Investigator# 23964
city: Baia Mare
country: Romania
facility: Site Reference ID/Investigator# 23303
city: Brasov
country: Romania
facility: Site Reference ID/Investigator# 23302
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 17962
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 17964
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 23304
city: Cluj Napoca
country: Romania
facility: Site Reference ID/Investigator# 17961
city: Craiova
country: Romania
facility: Site Reference ID/Investigator# 23305
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 24422
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 25063
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 25065
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 24423
city: A Coruna
country: Spain
facility: Site Reference ID/Investigator# 22809
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 22807
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 22804
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 22801
city: Pamplona Navarra
country: Spain
facility: Site Reference ID/Investigator# 22803
city: Santander
country: Spain
facility: Site Reference ID/Investigator# 22800
Study officials:
affiliation: AbbVie
name: Mark D. McKee, MD
role: STUDY_DIRECTOR
References: