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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01326000
First received: March 29, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  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:

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

  Show 56 Study Locations
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 June 18, 2013