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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326000
• Other study ID #: BP25438
• Status: Completed
• Phase: Phase 2
• Start date: April 2011
• Est. completion date: December 2013

Study information

• Verified date: November 2022
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• FOLFIRI
standard iv chemotherapy
• RO5083945
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
• cetuximab
400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria		approximately 18 months
Secondary	Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria		approximately 18 months
Secondary	Duration of response: time from complete or partial response to disease progression or death		approximately 18 months
Secondary	Clinical benefit rate: stable disease for >6 weeks, complete response or partial response; tumour assessments by CT scan or MRI according to RECIST criteria		approximately 18 months
Secondary	Overall survival		approximately 18 months
Secondary	Safety: Incidence of adverse events		approximately 18 months
Secondary	Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa		approximately 18 months