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: October 20, 2014
Last verified: October 2014
  Purpose

This randomized, multicenter, open label study will evaluate the safety and effi cacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuxi mab or FOLFIRI alone as second line treatment in patients with metastatic colore ctal cancer. Patients will be randomized to receive RO5083945 (1400 mg intraveno usly on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv c hemotherapy 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: FOLFIRI
Drug: RO5083945
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: FOLFIRI
standard iv chemotherapy
Drug: RO5083945
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
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: FOLFIRI
standard iv chemotherapy
Drug: RO5083945
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326000

  Show 70 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: October 20, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014