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Clinical Trials/EUCTR2009-013099-38-DE
EUCTR2009-013099-38-DE
Active, not recruiting
Phase 1

Sequential first-line therapy in metastatic colorectal cancer with Capecitabine/FUFA, Irinotecan and Bevacizumab - Capecitabine/FUFA plus Bevacizumab versus Capecitabine/FUFA plus Irinotecan plus Bevacizumab as first-line therapy in metastatic colorectal cancer

Klinikum der Universität München, Anstalt des öffentlichen Rechts vertreten durch den Vorstand0 sites450 target enrollmentJune 4, 2010
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Conditionsmetastatic colorectal cancerMedDRA version: 20.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsAvastinCamptoXeloda

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
metastatic colorectal cancer
Sponsor
Klinikum der Universität München, Anstalt des öffentlichen Rechts vertreten durch den Vorstand
Enrollment
450
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 4, 2010
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Klinikum der Universität München, Anstalt des öffentlichen Rechts vertreten durch den Vorstand

Eligibility Criteria

Inclusion Criteria

  • •Female and male patients can be included in the trial when all following inclusion criteria are met:
  • •\- patient's informed consent in written form
  • •\- histologically confirmed metastatic colorectal cancer
  • •\- metastases are not resectable or the patient can not or does not wish to undergo surgical treatment
  • •\- no prior chemotherapy of the metastatic disease
  • •\- measurable metastases according to RECIST version 1\.1 (CT Thorax/Abdomen within 4 weeks before registration)
  • •\- age \= 18 years
  • •\- ECOG performance status 0\-1
  • •\- Life expectancy \> 3 months
  • •\- Evaluation of the KRAS status (decentralized conduction, result is no requirement at time of inclusion)

Exclusion Criteria

  • •A patient can not be included in the trial, if one of the following criteria is met:
  • •\- Primarily resectable metastases and patient’s wish to undergo surgical intervention
  • •\- Heart insufficiency grade III or IV (functional NYHA classification)
  • •\- Existing concomitant disease or condition, which classifies the patient unsuitable for the trial or would interfere with the patient’s safety
  • •\- Myocardial infarction, instable angina pectoris, cardiac angioplasty or stent placement within the last 6 months
  • •\- History of an arterial thromboembolism including stroke, transient ischemic attack or cerebrovascular disease within the last 6 months
  • •\- Severe bleeding within the last 6 months (excluding tumor bleeding before resection), coagulopathy or bleeding diathesis
  • •\- Abdominal or tracheo\-oesophageal fistulas, gastrointestinal perforations within the last 6 months prior to enrolment into the study
  • •\- not adequately controlled hypertension (defined as systolic blood pressure \> 150 mmHg and /or \>100 mmHg diastolic blood pressure) under antihypertensive therapy
  • •\- History of recurring thromboembolic events (\> 1 episode of deep vein thrombosis, peripherally embolism) during the last 2 years

Outcomes

Primary Outcomes

Not specified

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