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 - Full Text View

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:

MedlinePlus related topics: CT Scans Cancer Colorectal Cancer Nuclear Scans

Drug Information available for: Cetuximab

U.S. FDA Resources

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
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 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

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Locations

United States, California

Encinitas, California, United States, 92024

La Jolla, California, United States, 92037

La Verne, California, United States, 91750

Los Angeles, California, United States, 90033

San Diego, California, United States, 92013

San Diego, California, United States, 92123

Santa Monica, California, United States, 90404
United States, Illinois

Harvey, Illinois, United States, 60426
United States, Nebraska

Grand Island, Nebraska, United States, 68803
United States, North Carolina

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
Australia

Adelaide, Australia, 5041

East Bentleigh, Australia, VIC 3165

Frankston, Australia, 3199

Melbourne, Australia, 3128

Newcastle, Australia, 2298

Port Macquarie, Australia, 2444
Belgium

Bruxelles, Belgium, 1200

Edegem, Belgium, 2650

Gent, Belgium, 9000

Leuven, Belgium, 3000
France

Bordeaux, France, 33000

Paris, France, 75679

Saint Herblain, France, 44805

Toulouse, France, 31052
Germany

Hamburg, Germany, 20251

Hannover, Germany, 30625

Heidelberg, Germany, 69120

Regensburg, Germany, 93049
Italy

Milano, Italy, 20141

Milano, Italy, 20162

Milano, Italy, 20132

Napoli, Italy, 80131

Pavia, Italy, 27100

Udine, Italy, 33100
Poland

Olsztyn, Poland, 10-228

Szczecin, Poland, 70-111
Spain

Barcelona, Spain, 08036

Barcelona, Spain, 08035

Madrid, Spain, 28041

Madrid, Spain, 28050

Sabadell, Spain, 08208

Santander, Spain, 39008

Sevilla, Spain, 41013

Valencia, Spain, 46010
United Kingdom

Aberdeen, United Kingdom, AB25 2ZN

Belfast, United Kingdom, BT9 7AB

Cardiff, United Kingdom, CF14 2TL

Glasgow, United Kingdom, G12 0YN

London, United Kingdom, SE1 9RT

London, United Kingdom, WC1E 6DD

London, United Kingdom, SW3 6JJ

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:	May 13, 2013
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 May 22, 2013