Positron Emission Tomography - Computed Tomography (PET-CT) Cetuximab Project - Full Text View

Sponsored by:	Universitaire Ziekenhuizen Leuven
Information provided by:	Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT00828620

Purpose

Molecular imaging with positron emission tomography (PET) using [18F] fluorodeoxyglucose (FDG) has been suggested as an early, sensitive marker of tumour response to anticancer drugs by monitoring the changes in glucose metabolism in tumours. Recently, FDG-PET has shown to be highly sensitive in detecting early response in other tumours. In this study, the investigators will prospectively investigate the role of early FDG-PET (at day 7 and week 6) in outcome prediction.

Condition	Intervention
Metastatic Colorectal Cancer	Other: Imaging study

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Imaging for Early Response Prediction to EGF-Receptor Blocking Monoclonal Antibodies in Combination Therapy for Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:

PET response on day 7 [ Time Frame: day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine whether the PET criteria for response on day 7 correlates with the CT criteria of minimum 10% decrease in tumour size (RECIST) at week 6 [ Time Frame: week 6 ] [ Designated as safety issue: No ]
To define the optimal cutoff value of SUVmax and their predictive value [ Time Frame: at day 7 and week 6 ] [ Designated as safety issue: No ]
To explore the test/retest reliability of PET/CT in this setting [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
To assess the value of PET/CT at day 7 in predicting overall survival [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
To asses the correlations between biomarkers and PET changes after Cetuximab [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	80
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
PET-CT Patients with Unresectable stage IV colorectal cancer; eligible for 3rd line Irinotecan and Cetuximab	Other: Imaging study PET-CT

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

unresectable stage IV colorectal cancer pathologically proven measurable disease (RECIST) K-RAS wild type Eligible for 3rd line Irinotecan + Cetuximab Able for tolerate PET/CT imaging Serum glucose < 200mg/dl

Criteria

Inclusion Criteria:

Histologically or cytologically proven colorectal cancer
Unresectable stage IV disease
K-Ras wild type tumour
Patients scheduled to undergo chemotherapy with irinotecan and cetuximab

Exclusion Criteria:

Prior abdominal/pelvic radiotherapy, surgery or chemotherapy within 3 months prior to inclusion in the study
Poorly controlled diabetes
Concomitant serious illness, such as uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled hypertension, infection
Symptomatic brain metastases
Pregnancy or participants of reproductive potential who are sexually active and not willing/able to use medically appropriate contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828620

Locations

Belgium
UZLeuven
Leuven, Belgium, 3000
ZNA Middelheim
Antwerpen, Belgium
Sint Augustinus Ziekenhuis
Wilrijk, Belgium

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

Principal Investigator:

Eric Van Cutsem, Prof.Dr

UZ Leuven

More Information

No publications provided

Responsible Party:	UZ Leuven ( Prof. Dr. Eric Van Cutsem )
Study ID Numbers:	s51276 - ML5241
Study First Received:	January 23, 2009
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00828620 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Cetuximab
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009