Clinical trial NCT01326000: A Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With Metastatic Colorectal Cancer
Official title: A Randomized, Multicenter, Open-label Phase II Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With KRAS Wild-type or Mutant Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-03-30
Enrollment: 169
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 randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Carcinoma of the colon and/or rectum
* Disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease
* ECOG performance status 0-1
* Adequate hematological, renal and liver function

Exclusion Criteria:

* Prior treatment with monoclonal antibody/small molecule against epidermal growth factor receptor (EGFR)
* Prior treatment with irinotecan
* Radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief)
* CNS metastasis
* History of or active autoimmune disorders/conditions

Primary outcomes:
measure: Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria
timeFrame: approximately 18 months
Secondary outcomes:
measure: Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria
timeFrame: approximately 18 months
measure: Duration of response: time from complete or partial response to disease progression or death
timeFrame: approximately 18 months
measure: Clinical benefit rate: stable disease for >6 weeks, complete response or partial response; tumour assessments by CT scan or MRI according to RECIST criteria
timeFrame: approximately 18 months
measure: Overall survival
timeFrame: approximately 18 months
measure: Safety: Incidence of adverse events
timeFrame: approximately 18 months
measure: Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa
timeFrame: approximately 18 months
Other outcomes:
Locations:
city: Encinitas
country: United States
state: California
city: Highland
country: United States
state: California
city: La Jolla
country: United States
state: California
city: La Verne
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Harvey
country: United States
state: Illinois
city: Skokie
country: United States
state: Illinois
city: Skokie
country: United States
state: Illinois
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Sayre
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Newcastle
country: Australia
state: New South Wales
city: Port Macquarie
country: Australia
state: New South Wales
city: Adelaide
country: Australia
state: South Australia
city: Box Hill
country: Australia
state: Victoria
city: EAST Bentleigh
country: Australia
state: Victoria
city: Frankston
country: Australia
state: Victoria
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Bordeaux
country: France
city: Brest
country: France
city: Lille
country: France
city: Paris
country: France
city: Saint Herblain
country: France
city: Toulouse
country: France
city: Essen
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Herne
country: Germany
city: Regensburg
country: Germany
city: Napoli
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Olsztyn
country: Poland
city: Szczecin
country: Poland
city: Sabadell, Barcelona
country: Spain
state: Barcelona
city: Santander
country: Spain
state: Cantabria
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Aberdeen
country: United Kingdom
city: Belfast
country: United Kingdom
city: Bournemouth
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Dorchester
country: United Kingdom
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Northwood
country: United Kingdom
city: Romford
country: United Kingdom
city: Weston Super Mare
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: