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

Hellenic Oncology Research Group

Status and phase: Completed; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Bevacizumab; Drug: Capecitabine; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01024504

CT/06.12

Details and patient eligibility

About

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.

Full description

Capecitabine, oxaliplatin and bevacizumab are well known active agents in the treatment of mCRC. The treatment of elderly patients with mCRC is an area of investigation. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

Enrollment: 46 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

XELOX/Avastin

Experimental group

Description:

Capecitabine Oxaliplatin Bevacizumab

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine

Drug: Bevacizumab