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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2010 by Ludwig-Maximilians - University of Munich
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01249638
First received: November 29, 2010
Last updated: March 11, 2011
Last verified: November 2010

November 29, 2010
March 11, 2011
December 2010
December 2013   (final data collection date for primary outcome measure)
TFS [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Time of Failure Strategy
Same as current
Complete list of historical versions of study NCT01249638 on ClinicalTrials.gov Archive Site
ORR, OS, Quality of Life, PFS-1 [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cap+Bev vs Cap+Iri+Bev 1st-line Therapy in mCRC
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer Metastatic
  • 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
  • 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
Giessen C, von Weikersthal LF, Hinke A, Stintzing S, Kullmann F, Vehling-Kaiser U, Mayerle J, Bangerter M, Denzlinger C, Sieber M, Teschendorf C, Freiberg-Richter J, Schulz C, Modest DP, Moosmann N, Aubele P, Heinemann V. A randomized, phase III trial of capecitabine plus bevacizumab (Cape-Bev) versus capecitabine plus irinotecan plus bevacizumab (CAPIRI-Bev) in first-line treatment of metastatic colorectal cancer: the AIO KRK 0110 trial/ML22011 trial. BMC Cancer. 2011 Aug 23;11:367. doi: 10.1186/1471-2407-11-367.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
516
December 2016
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Volker Heinemann, Prof. Dr. +49 89 7095 0 volker.heinemann@med.uni-muenchen.de
Germany
 
NCT01249638
ML22011
Yes
Volker Heinemann, Prof. Dr. med., University of Munich - Klinikum der Universitaet Muenchen
Ludwig-Maximilians - University of Munich
Roche Pharma AG
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
Ludwig-Maximilians - University of Munich
November 2010

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