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

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024504
• Other study ID #: CT/06.12
• Status: Completed
• Phase: Phase 2
• First received: November 26, 2009
• Last updated: April 8, 2010
• Start date: March 2006
• Est. completion date: March 2010

Study information

• Verified date: April 2010
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
Greece	Air Forces Military Hospital of Athens	Athens
Greece	IASO General Hospital of Athens, 1st Dep of Medical Oncology	Athens
Greece	Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Athens
Greece	State General Hospital of Larissa	Larissa
Greece	Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		2 - 4 months	No
Secondary	Toxicity profile		Toxicity assessment on each cycle	Yes
Secondary	Time to tumor progression		1 year	No
Secondary	Overall survival		1 year	No