Irinotecan, Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients (AVAXIRI)

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier:
NCT00875771
First received: March 30, 2009
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to determine efficacy and safety of the biweekly scheme with Capecitabine and Irinotecan, plus bevacizumab in patients with metastatic colorectal cancer.


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: Capecitabine+Irinotecan+Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan, Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients

Resource links provided by NLM:


Further study details as provided by Spanish Cooperative Group for Digestive Tumour Therapy (TTD):

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival (SG) [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]
  • Overall Response rate [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 2009-2012 ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]
  • Rate of hepatic metastases resection [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: April 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
  • Capecitabine: 1000 mg/m2, bid, oral, days 2-8. Every 2 weeks
  • Irinotecan: 175 mg/m2, iv infusion 90 minutes, day 1, every 2 weeks
  • Bevacizumab: 5 mg/kg day 1, every 2 Weeks
Drug: Capecitabine+Irinotecan+Bevacizumab
  • Capecitabine: 1000 mg/m2, bid, oral, days 2-8. Every 2 weeks
  • Irinotecan: 175 mg/m2, iv infusion 90 minutes, day 1, every 2 weeks
  • Bevacizumab: 5 mg/kg day 1, every 2 Weeks

Treatment will be given until disease progression or unacceptable toxicity.


Detailed Description:

The purpose of this study is to determine efficacy and safety of the biweekly scheme with Capecitabine and Irinotecan, plus bevacizumab in patients with metastatic colorectal cancer.

  • Capecitabine: 1000 mg/m2, bid, oral, days 2-8. Every 2 weeks
  • Irinotecan: 175 mg/m2, iv infusion 90 minutes, day 1, every 2 weeks
  • Bevacizumab: 5 mg/kg day 1, every 2 Weeks
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years old (men and women)
  2. ECOG Performance Status ≤ 2.
  3. Histologically confirmed colorectal adenocarcinoma, metastatic disease.
  4. No surgery option
  5. No previous chemotherapy, except adjuvant treatment finished at least 6 months before the study inclusion
  6. Have at least one measurable lesion according to the RECIST criteria
  7. At least a 3-month life expectancy.
  8. Written informed consent given.

Exclusion Criteria:

  1. Patients who have previously received systemic treatment (for example, cytostatic chemotherapy or active/passive immunotherapy) for advanced or metastatic disease.
  2. Patients previously treated with bevacizumab
  3. Prior adjuvant or neoadjuvant treatment for non-metastatic disease (M0) is allowed, as long as it has concluded at least 6 months before beginning the treatment of the study.
  4. If adjuvant treatment has previously been administered, the patients cannot have shown progression of the disease during treatment nor during the 6 months following termination thereof.
  5. Prior radiotherapy is allowed if it has not been administered in the target lesions selected for this study, unless progression of said lesions in the irradiated field is documented, and as long as treatment has concluded at least 4 weeks before beginning the study.
  6. Prior surgical treatment of the disease in stage IV is allowed.
  7. Only non evaluable disease (non measurable) as ascitis, pleural effusion, diffuse hepatic, osseous metastasis
  8. History of another neoplastic disease during the last five years, with the exception of cured basal cell carcinoma of the skin and cervical carcinoma in situ.
  9. History or indications of CNS disease (for example, primary brain tumor, uncontrolled convulsions with standard medical treatment, cerebral metastases of any type or history of ictus) in the physical examination.
  10. Medication or peripheral vascular disease, grade II or higher. Furthermore, those patients who have had a myocardial infarction in the year prior to beginning the treatment of the study will be excluded.
  11. History of psychiatric disability that the investigator considers clinically significant, which prevents the patient from granting the informed consent or interferes with compliance of taking the oral medication
  12. Clinically significant cardiovascular disease (i.e., active), for example, uncontrolled hypertension, unstable angina, congestive heart failure, class II or higher of the New York Heart Association (NYHA), severe cardiac arrhythmia
  13. Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication.
  14. Patients subjected to organ allografts who require immunosuppressive treatment.
  15. Severe, non-cicatrized osseous fractures, wounds or ulcers.
  16. Indications of hemorrhagic diathesis or coagulopathy.
  17. Severe, uncontrolled intercurrent infections or other severe, uncontrolled concomitant diseases.
  18. Moderate or severe renal failure [creatinine clearance lower than 30 ml/min (calculated according to the Cockcroft-Gault Formula)] or serum creatinine > 1.5 x upper limit of normal (ULN).
  19. Any of the following laboratory values:

    • Absolute neutrophils count (ANC) ≤ 1.5 x 109/l.
    • Platelet count ≤ 100 x 109/l.
    • Hemoglobin ≤ 9 g/dl.
    • INR > 1.5.
    • Total bilirubin >1.5 ULN.
    • ALS and/or AST > 2.5 x ULN or > 5 x ULN (in case of hepatic metastasis).
    • Alkaline phosphatase > 2.5 x ULN or 5 x ULN (in case of hepatic metastasis), or > 10 x ULN (in case of bone metastasis).
  20. History of unexpected serious adverse events to fluoropyrimidine treatments or known dihidropyrimidine dehydrogenase (DPD) deficiency.
  21. Patients subjected to major surgical procedure, open biopsy or patients have been significant traumatic injures in 28 days time before the initial study treatment, or patients with a major surgery procedure planning during the study period. Fine needle aspiration biopsy 7 days before the initial study.
  22. Use of full dose of oral or parenteral anticoagulants ( at least 10 days before the initial study treatment or thrombolytic agents. Low dose of warfarin is allowed, with an INR ≤ 1.5
  23. Subject requiring chronic use of high dose aspirin (> 325 m/day) or non-steroidal anti-inflammatory treatment (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases).
  24. Pregnant (serum positive pregnancy test) or lactating women.
  25. Received any investigational drug or agent/ procedure, i.e. participation in another treatment trial within 30 days of randomisation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875771

Locations
Spain
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, Spain
Sponsors and Collaborators
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
Hoffmann-La Roche
Investigators
Study Chair: Pilar García Alfonso, MD Hospital Gregorio Marañón. Madrid. Spain
Study Chair: Enrique Aranda, MD; phD Hospital Reina Sofía. Cordoba. Madrid
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier: NCT00875771     History of Changes
Other Study ID Numbers: TTD-08-03, EudraCT number:2008-004688-20
Study First Received: March 30, 2009
Last Updated: February 19, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Cooperative Group for Digestive Tumour Therapy (TTD):
metastatic colorectal cancer
BEVACIZUMAB
CAPECITABINE
IRINOTECAN

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Capecitabine
Bevacizumab
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014