1stline Study Capecitabine Administered on Continuous Way Plus Oxaliplatin&Bevacizumab Every 2weeks in Metastatic CCR.

Metastatic Colorectal Cancer Clinical Trial

Official title:

Phase II Study of First Line Capecitabine Administered on Continuous Way Combined With Oxaliplatin and Bevacizumab Every Two Weeks in Metastatic Colorectal Cancer Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345696
• Other study ID #: XELOXAVBISEMANAL
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2006
• Last updated: August 23, 2011
• Start date: June 2006
• Est. completion date: January 2011

Study information

• Verified date: August 2011
• Source: Unidad Integral de Investigación en Oncología S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determinate progression free survival after 9 months of treatment.

Description:

To look for a new chemotherapy management to get less acute and chronic toxicity and/or an easier administration treatment line.

This study tries to demonstrate an alternative chemotherapy scheme,continuous polychemotherapy regimen with less dose with the added effect of the monoclonal antibody Bevacizumab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2011
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women > or = 18 years

• Outpatients with ECOG performance status = 2.

• Histologically confirmed diagnosis of CRC patients with metastasis.

• Presence of at least one detectable lesion in accordance with RECIST criteria.

• Life expectancy greater than 3 months.

• Patients who are able to understand the study request and want to participate.

• Written informed consent given

Exclusion Criteria:

• Patients who have been treated with Bevacizumab previously.

• Received any systemic treatment previously to treat an advanced or metastatic disease

• Adjuvant or neoadjuvant treatment to non-metastatic disease is allowed, provided that there has been finished at least 6 months before the initial study treatment.

• If the patient has been treated with adjuvant therapy previously, it is not allowed to be included in the study in case of disease progression during the treatment or during 6 months later than the end of the treatment.

• If radiotherapy has been administered it has not been administered in the lesion selected for the study, and the end of the treatment has been finished at least 4 weeks before the study initiation.

• Previous surgical procedure of the IV stage disease is allowed.

• PAst or current history (within the last 5 years) of malignancies except curatively treated basal and squamous cell carcinoma of the skin, and in-situ carcinoma of the cervix.

• History or evidence upon physical examination of central nervous system (CNS) (i.e. primary cerebral tumour, uncontrolled convulsions with standard medical treatment, cerebral metastasis or any kind or ictus history).

• History of psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.

• Clinically significant cardiovascular disease (active), i.e, uncontrolled hypertension, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication or peripheral vascular disease. Patients have undergone myocardial infarction in the previous year of the study initiation will be excluded.

• Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medications

• Patients subjected to allogenic transplant and request immunotherapy.

• Bone fracture not healed, wounds or severe ulcers.

• Known hemorrhagic diathesis or coagulopathy.

• Uncontrolled and severe intercurrent infections or another severe and uncontrolled concomitant diseases.

• Moderate or severe renal impairment (creatinine clearance < 30 ml/min (calculated according to Cockroft-Gault formula) or serum creatinine >1,5 x ULN.

• 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. ALT 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).

• History of unexpected serious adverse events to fluoropyrimidine treatments or known dihydropyrimidine dehydrogenase (DPD) deficiency.

• Patients subjected to major surgical procedure, open biopsy or who had significant traumatic injures in 28 days time before the start of the study treatment , or patients with a major surgery procedure planning during the study period. Fine needle aspiration biopsy 7 days before the study initiation.

• Use of full dose of oral or parenteral anticoagulants ( at least 10 days before the start of the study treatment or thrombolytic agents. Low dose of warfarin is allowed, with an INR = 1.5.

• Subject requiring chronic use of high dose aspirin (> 325 m/day) or non-steroidal anti-inflammatory treatment.

• Participation in another treatment trial within 4 weeks of the study initiation.

• Pregnant (serum positive pregnancy test) or lactating women.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Bevacizumab
5 mg/Kg intravenous, 90-60-30 minutes, every 2 weeks.
• Capecitabine
600 mg/m2, orally, every 12 hours, continuous.
• Oxaliplatine
85 mg/m2, intravenous, 2 hours infusion, every 2 weeks

Locations

Country	Name	City	State
Spain	Hospital 12 de Octubre	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Unidad Integral de Investigación en Oncología S.L.	Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		9 months	No
Secondary	Overall Response rate		24 months	No
Secondary	Overall survival		24 months	No
Secondary	Toxicity of the combination of capecitabine+oxaliplatin+bevacizumab		24 months	Yes
Secondary	Resection rate of hepatic or pulmonary metastases		24 months	No