Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer

NCT01024504 | Completed Phase 2

• 1 other identifier: CT/06.12
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 6

Brief Summary

This trial will evaluate the efficacy and safety of the capecitabine and oxaliplatine plus bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer.

Conditions

Metastatic Colorectal Cancer

Keywords

Cancer; Colorectal cancer; Elderly; Chemotherapy; Capecitabine; Oxaliplatin; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  2 - 4 months

Secondary Outcomes (3)

• Toxicity profile

  Toxicity assessment on each cycle

• Time to tumor progression

  1 year

• Overall survival

  1 year

Study Arms (1)

XELOX/Avastin

EXPERIMENTAL

Capecitabine Oxaliplatin Bevacizumab

Drug: Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab

Interventions

Oxaliplatin DRUG

Oxaliplatin at the dose of 85 mg/m2 over a 4 hour intravenous infusion at day 1 every 2 weeks for a maximum of 12 consecutive cycles

Also known as: Eloxatin

XELOX/Avastin

Capecitabine DRUG

Capecitabine at the dose of 1500 mg/m2 per os at days 1 to 7 every 2 weeks for a maximum of 12 consecutive cycles

Also known as: Xeloda

XELOX/Avastin

Bevacizumab DRUG

Bevacizumab at the dose of 5 mg/Kgr (intravenous infusion) at day 1, every 2 weeks for a maximum of 12 consecutive cycles

Also known as: Avastin

XELOX/Avastin

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the colon or rectum
• Stage IV
• Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated.
• Absence or irradiated and stable central nervous system metastatic disease.
• Life expectancy of more than 3 months.
• Age ≥ 70 years.
• Performance status (WHO) ≤ 2.
• Adequate bone marrow function (Absolute neutrophil count \>1000/mm3, Platelet count \>100000/mm3, Hemoglobin \>9gr/mm3).
• Adequate liver (Bilirubin \<1.5 times upper limit of normal and SGOT/SGPT \<2 times upper limit of normal).
• Creatinine clearance (Cockcroft-Gault formula) \>30ml/min.
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
• Presence of a reliable care giver.
• Informed consent.

You may not qualify if:

• Prior chemotherapy for metastatic disease.
• History of thromboembolic disease or myocardial infraction within the last 6 months.
• Peripheral neuropathy ≥ grade 2.
• Bowel obstruction or chronic diarrhea.
• Psychiatric illness or social situation that would preclude study compliance.
• Other concurrent uncontrolled illness.
• Other concurrent investigational agents.

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (6)

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

IASO General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

State General Hospital of Larissa

Larissa, Greece

Location

Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

Related Publications (1)

• Vamvakas L, Matikas A, Karampeazis A, Hatzidaki D, Kakolyris S, Christophylakis C, Boukovinas I, Polyzos A, Georgoulias V, Souglakos J. Capecitabine in combination with oxaliplatin and bevacizumab (AXELOX) as 1st line treatment for fit and vulnerable elderly patients (aged >70 years) with metastatic colorectal cancer (mCRC): a multicenter phase II study of the Hellenic Oncology Research Group (HORG). BMC Cancer. 2014 Apr 22;14:277. doi: 10.1186/1471-2407-14-277.

  PMID: 24755296 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Interventions

Oxaliplatin; Capecitabine; Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• John Souglakos, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

• Lampros Vamvakas, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 26, 2009
• First Posted: December 2, 2009
• Study Start: March 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 9, 2010

Record last verified: 2010-04

Locations

GR (6)