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Cap+Bev vs Cap+Iri+Bev 1st-line Therapy in mCRC

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ClinicalTrials.gov Identifier: NCT01249638
Recruitment Status : Unknown
Verified November 2010 by Ludwig-Maximilians - University of Munich.
Recruitment status was:  Recruiting
First Posted : November 30, 2010
Last Update Posted : March 14, 2011
Roche Pharma AG
Information provided by:
Ludwig-Maximilians - University of Munich

Brief Summary:
Patient with multiple metastases, not eligible for surgery, might not profit from intensive chemotherapy regimens. Therefore less intensive regimens focusing on survival and disease control may be a better choice for first line treatment. Therefore this study investigates the combination of capecitabine and bevacizumab versus the combination of capecitabine, bevacizumab and irinotecan. In case of progressive disease, the therapy in patients treated with capecitabine and bevacizumab is intensified by adding irinotecan. Primary endpoint is time-of-failure strategy (TFS) comparing both treatment arms.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Drug: Capecitabine Drug: Bevacizumab Drug: Irinotecan Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 516 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open, Multicenter Phase III Study With Capecitabine Plus Bevacizumab Versus Capecitabine Plus Irinotecan Plus Bevacizumab as First-line Therapy in Patients With Metastatic Colorectal Cancer
Study Start Date : December 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cap+Bev until PD followed by CAPIRI +Bev

Capecitabine + Bevacizumab

In case of Progression Escalation to:

Capecitabine + Irinotecan + Bevacizumab

Drug: Capecitabine
Capecitabine:2 x 1250 mg/m2 day 1-14 followed by 1 week pause q day 21

Drug: Bevacizumab
Bevacizumab: 7.5 mg/kg day 1 q day 21

Active Comparator: Capiri + Bev
Capecitabine + Irinotecan + Bevacizumab
Drug: Capecitabine
Capecitabine: 2 x 800mg/m2 day 1-14 followed by 1 week pause q day 21

Drug: Irinotecan
Irinotecan: 200 mg/m2 day 1 , q day 21

Drug: Bevacizumab
Bevacizumab: 7.5 mg/kg day 1, q day 21

Primary Outcome Measures :
  1. TFS [ Time Frame: 9 months ]
    Time of Failure Strategy

Secondary Outcome Measures :
  1. ORR, OS, Quality of Life, PFS-1 [ Time Frame: 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the colon or rectum.
  • Stage IV disease.
  • ECOG 0-1.
  • Patients considered suitable for application of chemotherapy.
  • Age 18 - 75 years.
  • In- or outpatient treatment.
  • Estimated life expectancy > 3 months.
  • Measurable index lesion according to RECIST criteria. Evaluation of tumor manifestations ≤ 2 weeks prior to treatment start.
  • Effective contraception.
  • Adequate hematologic function: leukocytes >= 3000/µl, neutrophils >= 1500/µl, platelets >= 100.000/µ, and hemoglobin >= 9g/dl. Bilirubin <= 1,5x upper limit of normal (ULN). ALAT and ASAT <= 2,5x ULN, in case of liver metastases <= 5x ULN. Serum creatinine <= 1,5x ULN.
  • No operations within 4 weeks prior to treatment start. No cytologic biopsies within 1 week prior to treatment start. Operation sequels need to be completely healed. Major operations must not be expected at time of study begin, except for potential secondary resection of liver metastases. In case of secondary resection of liver metastases, bevacizumab must be discontinued 6-8 weeks prior to surgery.
  • No relevant toxicities due to prior medical treatment at time of study entry.

Exclusion Criteria:

  • primary resectable metastases
  • heart failure Grade III/IV (NYHA-classification)
  • Prior treatment directed against the epidermal growth factor receptor (EGFR).
  • Prior treatment with bevacizumab.
  • Prior chemotherapy for colorectal cancer, except for adjuvant chemotherapy dating back > 6 months prior to study entry.
  • Experimental medical treatment within 30 days prior to study entry.
  • Known hypersensitivity reaction to any study medication.
  • Pregnant or breast feeding women (pregnancy needs to be excluded by testing of beta-HCG).
  • Known or suspected cerebral metastases.
  • Clinically significant coronary heart disease, myocardial infarction within the last 12 months or high risk of uncontrolled arrhythmia.
  • Acute or subacute ileus, chronic inflammatory bowel disease or chronic diarrhea.
  • Abdominal or tracheo-esophageal fistulas, gastrointestinal perforation within 6 months before study entry
  • Symptomatic peritoneal carcinosis.
  • Severe chronic wounds, ulcera or bone fracture.
  • Uncontrolled hypertension.
  • Severe proteinuria (nephrotic syndrome).
  • Arterial thromboembolic events or hemorrhage within 6 months prior to study entry (except tumor bleeding surgically treated by tumor resection).
  • Bleeding diatheses or coagulopathy.
  • Full dose anticoagulation.
  • Known DPD-deficiency (special screening not required).
  • Known glucuronidation-deficiency (special screening not required).
  • Contraindication with irinotecan
  • Medical history of other malignant disease within 5 years prior to study entry, except for basalioma, and in-situ cervical carcinoma if treated with curative intent.
  • Known alcohol or drug abuse.
  • Medical or psychiatric condition which contradicts participation of study.
  • Limited legal capacity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249638

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Contact: Volker Heinemann, Prof. Dr. +49 89 7095 0 volker.heinemann@med.uni-muenchen.de

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University of Munich - Klinikum der Universitaet Muenchen Recruiting
Munich, Germany, 81377
Contact: Volker Heinemann, Prof. Dr. med.    +49 89 7095 0    volker.heinemann@med.uni-muenchen.de   
Contact: Clemens Giesse, Dr. med.    +49 89 7095 0    clemens.giessen@med.uni-muenchen.de   
Principal Investigator: Volker Heinemann, Prof. Dr. med.         
Sub-Investigator: Clemens Giessen, Dr. med.         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Roche Pharma AG
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Principal Investigator: Volker Heinemann, Prof. Dr. med. University of Munich - Klinikum der Universitaet Muenchen
Study Chair: Sebastian Stintzing, Dr. med. University of Munich - Klinikum der Universitaet Muenchen
Study Chair: Clemens Giessen University of Munich - Klinikum der Universitaet Muenchen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Volker Heinemann, Prof. Dr. med., University of Munich - Klinikum der Universitaet Muenchen
ClinicalTrials.gov Identifier: NCT01249638    
Other Study ID Numbers: ML22011
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: March 14, 2011
Last Verified: November 2010
Keywords provided by Ludwig-Maximilians - University of Munich:
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors