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OpenTrials
Completed

NCT Number: NCT01326000

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 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Newcastle, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOLFIRI

Drug

standard iv chemotherapy

RO5083945

Drug

1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter

Cetuximab

Drug

400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week

Primary outcomes

  1. Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria

    Time frame: approximately 18 months

Secondary outcomes

  1. Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria

    Time frame: approximately 18 months

  2. Duration of response: time from complete or partial response to disease progression or death

    Time frame: approximately 18 months

  3. 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

  4. Overall survival

    Time frame: approximately 18 months

  5. Safety: Incidence of adverse events

    Time frame: approximately 18 months

  6. Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa

    Time frame: approximately 18 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 30, 2011
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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