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Clinical Trials/EUCTR2005-005154-44-AT
EUCTR2005-005154-44-ATActive, not recruitingNot Applicable

OPERA: OXALIPLATIN AND CETUXIMAB IN FIRST-LINE TREATMENT OF mCRCOpen, non-controlled, multicenter phase II study evaluating 5-FU/FA plus oxaliplatin (FOLFOX-4) plus cetuximab as first-line treatment for patients with undetectable EGFR-status in metastatic colorectal cancer. - OPERA

niversitätsklinikum Hamburg-Eppendorf0 sites72 target enrollmentStarted: July 7, 2006Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
72
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Signed written informed consents
  • •Inpatient or outpatient =18 years of age
  • •Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
  • •1st occurrence of metastatic disease (not curatively resectable)
  • •EGFR-negative tumour
  • •Life expectancy of at least 12 weeks
  • •Presence of at least 1 bi-dimensionally measurable index lesion (not in an irradiated area)
  • •ECOG performance status of = 2 at study entry
  • •Effective contraception for both male and female subjects if the risk of conception exists
  • •White blood cell count (WBC) = 3x109/L with neutrophils = 1.5x109/L, platelet count = 100x109/L, hemoglobin = 6.21 mmol/L (10 g/dL)
  • •ASAT and ALAT = 2.5 x upper reference range, or = 5 x upper reference range in case of liver metastasis
  • •Serum creatinine = 1.5 x upper reference range
  • •Recovery from relevant toxicity to previous treatment before study entry
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •Previous exposure to epidermal growth factor receptor-targeting therapy
  • •Previous oxaliplatin-based chemotherapy
  • •Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment
  • •Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before inclusion.
  • •Concurrent chronic systemic immune therapy or hormone therapy not indicated in this study protocol except physiologic replacement
  • •Known hypersensitivity reaction to any of the components of study treatments
  • •Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
  • •Brain metastasis and/or leptomeningeal disease (known or suspected)
  • •Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
  • •Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
  • •Previous malignancy other than colorectal cancer in the last 5 years except basal cell cancer of the skin or pre-invasive cancer of the cervix
  • •Known alcohol or drug abuse
  • •Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
  • •Participation in another clinical study within the 30 days before registration.
  • •Significant disease which, in the investigator’s opinion, would exclude the subject from the study
  • •Peripheral neuropathy > grade 1
  • •Legal incapacity or limited legal capacity

Investigators

Sponsor
niversitätsklinikum Hamburg-Eppendorf

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