Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Ludwig-Maximilians - University of Munich

Tracking Information
First Submitted Date  ICMJE November 29, 2010
First Posted Date  ICMJE November 30, 2010
Last Update Posted Date March 14, 2011
Study Start Date  ICMJE December 2010
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2010)
TFS [ Time Frame: 9 months ]
Time of Failure Strategy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2010)
ORR, OS, Quality of Life, PFS-1 [ Time Frame: 36 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cap+Bev vs Cap+Iri+Bev 1st-line Therapy in mCRC
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer Metastatic
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Cap+Bev until PD followed by CAPIRI +Bev

    Capecitabine + Bevacizumab

    In case of Progression Escalation to:

    Capecitabine + Irinotecan + Bevacizumab

    Interventions:
    • Drug: Capecitabine
    • Drug: Bevacizumab
  • Active Comparator: Capiri + Bev
    Capecitabine + Irinotecan + Bevacizumab
    Interventions:
    • Drug: Capecitabine
    • Drug: Irinotecan
    • Drug: Bevacizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 29, 2010)
516
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01249638
Other Study ID Numbers  ICMJE ML22011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Volker Heinemann, Prof. Dr. med., University of Munich - Klinikum der Universitaet Muenchen
Study Sponsor  ICMJE Ludwig-Maximilians - University of Munich
Collaborators  ICMJE Roche Pharma AG
Investigators  ICMJE
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
PRS Account Ludwig-Maximilians - University of Munich
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP