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Clinical Trials/EUCTR2006-000685-36-GR
EUCTR2006-000685-36-GR
Active, not recruiting
Not Applicable

A randomized, open-label phase II studyevaluating the efficacy and safety of FOLFOX-4plus cetuximab versus UFOX plus cetuximab asfirst-line therapy in subjects with metastaticcolorectal cancer - FUTURE

Merck KGaA0 sites420 target enrollmentJanuary 15, 2007
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DrugsUFT or Uftoral (UK,DK)5-FU HEXAL 50 mg/ml Injektionslösung (solution for injection containing 50mg/ml 5-FU)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Merck KGaA
Enrollment
420
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 15, 2007
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Merck KGaA

Eligibility Criteria

Inclusion Criteria

  • •Both male and female subjects are eligible for randomization.
  • •For inclusion in the study, all of the following inclusion criteria must be fulfilled:
  • •Subject has given written informed consent before any study\-related activities are carried out
  • •Inpatient or outpatient \=18 years of age
  • •Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum
  • •First occurrence of metastatic disease (at presentation not curatively resectable)
  • •Presence of at least one lesion unidimensionally measurable by CT\- and/or MRI\-scans. (target lesion(s) must not lie within an irradiated area)
  • •Life expectancy of \=3 months
  • •Karnofsky performance status of \=60 at study entry
  • •White blood cell count (WBC) \=3 x 10^9/L, with neutrophils \=1\.5 x 10^9/L, platelets \=100 x 10^9/L, and hemoglobin \=9 g/dL

Exclusion Criteria

  • •Subjects are not eligible for this study if they fulfill one or more of the following exclusion criteria:
  • •Brain metastasis and/or leptomeningeal disease (known or suspected)
  • •Previous chemotherapy for CRC except adjuvant treatment with progression of disease documented \>6 months after end of adjuvant treatment
  • •Previous oxaliplatin\-based chemotherapy
  • •Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization
  • •Concurrent or previous chronic systemic immune therapy, targeted therapy, anti\-VEGF therapy, or EGFR\-pathway targeting therapy not indicated in the study protocol
  • •Concurrent hormonal therapy not indicated in the study protocol except for physiologic replacement or contraception
  • •Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
  • •Peripheral neuropathy \>grade 1
  • •Known hypersensitivity reaction to any of the components of the treatment

Outcomes

Primary Outcomes

Not specified

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