Cetuximab Combined With Irinotecan in First-Line Therapy for Metastatic Colorectal Cancer (CRYSTAL) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 8, 2005

Last Updated Date

March 21, 2009

Start Date ^†

May 2004

Current Primary Outcome Measures ^†

Progression-free survival time under 5-FU/FA plus irinotecan with or without cetuximab [ Time Frame: various timepoints ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00154102 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Overall Survival time [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
Response Rate and Disease Control rate [ Time Frame: various timepoints ] [ Designated as safety issue: No ]
Duration or Response [ Time Frame: various timepoints ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: various timepoints ] [ Designated as safety issue: No ]
Safety [ Time Frame: various timepoints ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Overall Survival time
Response Rate and Disease Control rate
Duration or Response
Quality of Life
Safety

Descriptive Information

Brief Title ^†

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

Official Title ^†

Open, Randomized, Controlled, Multicenter Phase III Study Comparing 5FU/ FA Plus Irinotecan Plus Cetuximab Versus 5FU/FA Plus Irinotecan as First-Line Treatment for Epidermal Growth Factor Receptor-Expressing Metastatic Colorectal Cancer

Brief Summary

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/Folinic acid plus irinotecan) for metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone on patient expressing the 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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

EGFR-Expressing Metastatic Colorectal Cancer

Intervention ^†

Drug: Cetuximab, 5-Fluorouracil, Folinic acid, Irinotecan
Drug: 5-Fluorouracil, Folinic acid, Irinotecan

Study Arms / Comparison Groups

Publications *

Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pintér T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

1221

Estimated Completion Date

June 2009

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00154102

Responsible Party

Patrick Lebrun, Merck KGaA

Secondary IDs ^††

Study Sponsor ^†

Merck KGaA

Collaborators ^††

Investigators ^†

Principal Investigator:

Eric van Cutsem, Professor

University Hospital Gasthuisberg, Department Internal Medicine, Leuven, Belgium

Information Provided By

Merck KGaA

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.