Irinotecan, Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients

NCT00875771 | Completed Phase 2

• 2 other identifiers: TTD-08-03EudraCT number:2008-004688-20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Colorectal Cancer

Keywords

metastatic colorectal cancer; BEVACIZUMAB; CAPECITABINE; IRINOTECAN

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  2009-2012

Secondary Outcomes (6)

• overall survival (SG)

  2009-2012

• Overall Response rate

  2009-2012

• Toxicity

  2009-2012

• Duration of response

  2009-2012

• Quality of life

  2009-2012

Study Arms (1)

1

EXPERIMENTAL

* 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

Interventions

Capecitabine+Irinotecan+Bevacizumab DRUG

* 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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old (men and women)
• ECOG Performance Status ≤ 2.
• Histologically confirmed colorectal adenocarcinoma, metastatic disease.
• No surgery option
• Have at least one measurable lesion according to the RECIST criteria
• At least a 3-month life expectancy.
• Written informed consent given.

You may not qualify if:

• Patients who have previously received systemic treatment (for example, cytostatic chemotherapy or active/passive immunotherapy) for advanced or metastatic disease.
• Patients previously treated with bevacizumab
• 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.
• 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.
• 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.
• Prior surgical treatment of the disease in stage IV is allowed.
• Only non evaluable disease (non measurable) as ascitis, pleural effusion, diffuse hepatic, osseous metastasis
• 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.
• 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.
• 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.
• 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
• 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
• Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication.
• Patients subjected to organ allografts who require immunosuppressive treatment.
• Severe, non-cicatrized osseous fractures, wounds or ulcers.

Sponsors & Collaborators

• Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD): lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Spanish Cooperative Group for Gastrointestinal Tumour Therapy

Madrid, Spain

Location

Related Publications (1)

• Garcia-Alfonso P, Chaves M, Munoz A, Salud A, Garcia-Gonzalez M, Gravalos C, Massuti B, Gonzalez-Flores E, Queralt B, Lopez-Ladron A, Losa F, Gomez MJ, Oltra A, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Capecitabine and irinotecan with bevacizumab 2-weekly for metastatic colorectal cancer: the phase II AVAXIRI study. BMC Cancer. 2015 Apr 29;15:327. doi: 10.1186/s12885-015-1293-y.

  PMID: 25925749 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Pilar García Alfonso, MD

  Hospital Gregorio Marañón. Madrid. Spain

  STUDY CHAIR

• Enrique Aranda, MD; phD

  Hospital Reina Sofía. Cordoba. Madrid

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: April 3, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

ES (1)