Efficacy/Safety Study of Bevacizumab,Capecitabine,Oxaliplatin to Metastatic Colorectal Adenocarcinoma Elderly Patients.

NCT01067053 | Unknown Phase 2

• 1 other identifier: GEMCAD-0901
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to determine whether bevacizumab, capecitabine and oxaliplatin are an effective and safe first line of treatment for elderly patients with metastatic colorectal adenocarcinoma.

Conditions

Metastatic Colorectal Cancer

Keywords

Bevacizumab; Capecitabine; Oxaliplatin; Metastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Time to progression

  3 years

Secondary Outcomes (6)

• Overall survival

  3 years

• Objective response rate following Response Evaluation Criteria In Solid Tumors (RECIST) criteria

  3 years

• Overall response rate

  3 years

• Number of treatment cycles administered

  3 years

• Number of patients who have required dose reductions of either drug

  3 years

Study Arms (1)

bevacizumab, capecitabine, oxaliplatin

EXPERIMENTAL

6 cycles (3 weeks each one) of: * bevacizumab: 7,5 mg/kg (iv), 1st day of each cycle. * capecitabine: 1000 mg/m2 bid, oral. Days: 1-14 every three weeks. * oxaliplatin: 130/mg/m2(iv),1st day of each cycle. After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine

Drug: bevacizumab, capecitabine, oxaliplatin

Interventions

bevacizumab, capecitabine, oxaliplatin DRUG

6 cycles (3 weeks each one) of: * bevacizumab: 7,5 mg/kg (iv), 1st day of each cycle. * capecitabine: 1000 mg/m2 bid, oral. Days: 1-14 every three weeks. * oxaliplatin: 130/mg/m2(iv),1st day of each cycle. After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine

Also known as: bevacizumab (Avastin®), capecitabine (Xeloda®), oxaliplatin

bevacizumab, capecitabine, oxaliplatin

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Written informed consent.
• ECOG 0-1.
• Age ≥ 70 years.
• Histologically confirmed carcinoma of the colon and/or rectum.
• Metastatic disease non suitable for radical surgery.
• At least one measurable metastatic lesion (as per RECIST criteria). The index lesion must not be in a previously irradiated area.
• Life expectancy more than 3 months.
• Adequate renal function: creatinine ≤ 1.5 x UL and calculated creatinine clearance ≥ 30 mL/min.
• Adequate level function: AST and ALT ≤ 2.5 x UL (≤ 5 x UL if liver metastases), bilirubin ≤ 1.5 x UL.
• Adequate haematological function: Hb ≥ 9 gr/dl, neutrophils ≥ 1,5 x 109 /l and platelets ≥ 100000 x 109/l.
• Urine dipstick for proteinuria \< 2+. If urine dipstick is ≥ 2+, 24 hour urine must demonstrate ≤ 1 g of protein in 24 hours.
• No clinical evidence or history of metastatic CNS disease.
• No prior Bevacizumab treatment.

You may not qualify if:

• Patients who previously received bevacizumab.
• Prior chemotherapeutic treatment for metastatic CRC.
• Prior treatment with monoclonal antibodies.
• Clinical evidence of brain metastases or history or evidence upon physical examination of CNS disease unless adequately treated.
• Past or current history (within the last 5 years prior to treatment start) of other malignancies except metastatic colorectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
• Clinically significant cardiovascular disease, for example CVA (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2, CHF, arrhythmia requiring medication, or uncontrolled hypertension.
• Intestinal occlusion/subocclusion.
• Chronic diarrhea.
• Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study.
• Known hypersensitivity to any of the study drugs.
• Current or recent (within 10 days of first dose of study treatment) daily use of aspirin (\> 325 mg/day) or other NSAID.
• Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes. Patients receiving (or considered candidate to receive) anticoagulants agents as prophylaxis of cardiovascular risk, should continue (or start) the appropriate treatment at study entry.
• History of venous thromboembolic or haemorrhagic events within 6 months prior to treatment.
• Patients with previous of arterial thromboembolic event.
• Evidence of bleeding diathesis or coagulopathy.

Sponsors & Collaborators

• Grupo Espanol Multidisciplinario del Cancer Digestivo: lead

Study Sites (15)

Hospital Clinic i Provincial

Barcelona, Barcelona, 08036, Spain

Location

Hospital de L´Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08906, Spain

Location

Hospital General Yagüe

Burgos, Burgos, 09005, Spain

Location

Hospital de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

Location

Hospital Arnau de Vilanova

Lleida, Lérida, 25198, Spain

Location

Hospital Universitario la Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Quirón de Madrid

Madrid, Madrid, 28223, Spain

Location

Hospital Infanta Sofía

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Hospital Morales Meseguer

Murcia, Murcia, 30008, Spain

Location

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital La Fe de Valencia

Valencia, Valencia, 46009, Spain

Location

Hospital General de Valencia

Valencia, Valencia, 46014, Spain

Location

Hospital Doctor Peset

Valencia, Valencia, 46017, Spain

Location

Hospital Lluis Alcanyis

Xàtiva, Valencia, 46800, Spain

Location

Hospital Xeral Cies de Vigo

Vigo, Vigo, 36204, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Capecitabine; Oxaliplatin

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Jaime Feliu Batlle, MD

  Grupo Español Multidisciplinario de Cáncer Digestivo

  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: January 21, 2010
• First Posted: February 11, 2010
• Study Start: November 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: March 1, 2014
• Last Updated: January 9, 2014

Record last verified: 2014-01

Locations

ES (15)