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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01326000
First received: March 29, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: RO5083945
Drug: FOLFIRI
Drug: cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
  • Duration of response: time from complete or partial response to disease progression or death [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
  • Clinical benefit rate: stable disease for >6 weeks, complete response or partial response; tumour assessments by CT scan or MRI according to RECIST criteria [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
  • Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]

Enrollment: 169
Study Start Date: April 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KRAS WT A Drug: RO5083945
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
Drug: FOLFIRI
standard iv chemotherapy
Active Comparator: KRAS WT B Drug: FOLFIRI
standard iv chemotherapy
Drug: cetuximab
400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week
Experimental: KRAS mutant A Drug: RO5083945
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
Drug: FOLFIRI
standard iv chemotherapy
Active Comparator: KRAS mutant B Drug: FOLFIRI
standard iv chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326000

  Hide Study Locations
Locations
United States, California
Encinitas, California, United States, 92024
Highland, California, United States, 92346
La Jolla, California, United States, 92037
La Verne, California, United States, 91750
LaJolla, California, United States, 92037
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90095
San Diego, California, United States, 92123
United States, Illinois
Harvey, Illinois, United States, 60426
Skokie, Illinois, United States, 60077
Skokie, Illinois, United States, 60076
United States, North Carolina
Charlotte, North Carolina, United States, 28204
Durham, North Carolina, United States, 27710
Winston-salem, North Carolina, United States, 27103
United States, Pennsylvania
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Greenville, South Carolina, United States, 29615
United States, Tennessee
Memphis, Tennessee, United States, 38119
Australia, New South Wales
Newcastle, New South Wales, Australia, 2298
Port Macquarie, New South Wales, Australia, 2444
Australia, South Australia
Adelaide, South Australia, Australia, 5041
Australia, Victoria
Box Hill, Victoria, Australia, 3128
East Bentleigh, Victoria, Australia, VIC 3165
Frankston, Victoria, Australia, 3199
Belgium
Bruxelles, Belgium, 1200
Bruxelles, Belgium, 1000
Edegem, Belgium, 2650
Gent, Belgium, 9000
Leuven, Belgium, 3000
France
Bordeaux, France, 33075
Brest, France, 29200
Lille, France, 59037
Paris, France, 75679
Saint Herblain, France, 44805
Toulouse, France, 31059
Germany
Essen, Germany, 45122
Hamburg, Germany, 20246
Hannover, Germany, 30625
Heidelberg, Germany, 69120
Herne, Germany, 44625
Regensburg, Germany, 93049
Italy
Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40138
Udine, Friuli-Venezia Giulia, Italy, 33100
Milano, Lombardia, Italy, 20141
Milano, Lombardia, Italy, 20162
Milano, Lombardia, Italy, 20132
Pavia, Lombardia, Italy, 27100
Poland
Olsztyn, Poland, 10-228
Szczecin, Poland, 70-111
Spain
Sabadell, Barcelona, Barcelona, Spain, 08208
Santander, Cantabria, Spain, 39008
Barcelona, Spain, 08907
Barcelona, Spain, 08036
Barcelona, Spain, 08035
Madrid, Spain, 28041
Madrid, Spain, 28050
Sevilla, Spain, 41013
Valencia, Spain, 46010
United Kingdom
Aberdeen, United Kingdom, AB25 2ZN
Belfast, United Kingdom, BT9 7AB
Bournemouth, United Kingdom, BH7 7DW
Cardiff, United Kingdom, CF14 2TL
Dorchester, United Kingdom, DT1 2JY
Glasgow, United Kingdom, G12 0YN
London, United Kingdom, SW3 6JJ
London, United Kingdom, SE1 9RT
London, United Kingdom, WC1E 6DD
Northwood, United Kingdom, HA6 2RN
Romford, United Kingdom, RM7 0AG
Weston Super Mare, United Kingdom, BS23 4TQ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01326000     History of Changes
Other Study ID Numbers: BP25438
Study First Received: March 29, 2011
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014