Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01024504 |
Recruitment Status :
Completed
First Posted : December 2, 2009
Last Update Posted : April 9, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Colorectal Cancer | Drug: Oxaliplatin Drug: Capecitabine Drug: Bevacizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 46 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: XELOX/Avastin
Capecitabine Oxaliplatin Bevacizumab
|
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
Other Name: Eloxatin Drug: 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
Other Name: Xeloda Drug: Bevacizumab Bevacizumab at the dose of 5 mg/Kgr (intravenous infusion) at day 1, every 2 weeks for a maximum of 12 consecutive cycles
Other Name: Avastin |
- Overall response rate [ Time Frame: 2 - 4 months ]
- Toxicity profile [ Time Frame: Toxicity assessment on each cycle ]
- Time to tumor progression [ Time Frame: 1 year ]
- Overall survival [ Time Frame: 1 year ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024504
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, Greece |
Principal Investigator: | John Souglakos, MD | University Hospital of Crete, Dep of Medical Oncology | |
Principal Investigator: | Lampros Vamvakas, MD | University Hospital of Crete |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | John Souglakos, University Hospital of Crete |
ClinicalTrials.gov Identifier: | NCT01024504 History of Changes |
Other Study ID Numbers: |
CT/06.12 |
First Posted: | December 2, 2009 Key Record Dates |
Last Update Posted: | April 9, 2010 |
Last Verified: | April 2010 |
Cancer Colorectal cancer Elderly Chemotherapy |
Capecitabine Oxaliplatin Bevacizumab |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Bevacizumab |
Capecitabine Oxaliplatin Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |