Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)

Merck KGaA (EMD Serono) logo

Merck KGaA (EMD Serono)

Status and phase

Completed
Phase 3

Conditions

Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer

Treatments

Drug: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
Drug: Cetuximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00154102
EMR 62202-013

Details and patient eligibility

About

Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Giving combination chemotherapy together with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer ('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with cetuximab is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil (5FU)/Folinic acid (FA) plus irinotecan) for metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone on patient expressing the epidermal growth factor (EGF) receptor. Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to either receive the combination chemotherapy alone or with cetuximab (open-label study) and will then be treated until progression of the disease or unacceptable toxicity occur. Regular efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study together with regular safety assessments (e.g. safety labs). An independent Safety Board of experts will also monitor safety data. After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator. The entire study (from the first patient entering the study to the last collect of follow-up information) is 4-5 years long.

Enrollment

1,221 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
  • Inoperable metastatic disease
  • Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue
  • Presence of at least 1 bi-dimensionally measurable index lesion

Exclusion criteria

  • Previous irinotecan-based chemotherapy
  • Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment
  • Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of study treatment
  • Brain metastasis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,221 participants in 2 patient groups

Cetuximab Plus FOLFIRI
Experimental group
Treatment:
Drug: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
Drug: Cetuximab
FOLFIRI Alone
Active Comparator group
Treatment:
Drug: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)

Trial contacts and locations

154

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Data sourced from clinicaltrials.gov

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