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Clinical Trials/EUCTR2006-000685-36-FR
EUCTR2006-000685-36-FR
Active, not recruiting
Phase 1

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 sites0 target enrollmentNovember 30, 2006
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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
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Merck KGaA
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 30, 2006
End Date
May 15, 2012
Last Updated
4 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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