Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
This study has been completed.
Sponsor:
Hellenic Oncology Research Group
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01024504
First received: November 26, 2009
Last updated: April 8, 2010
Last verified: April 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Colorectal Cancer |
Drug: Oxaliplatin Drug: Capecitabine Drug: Bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Hellenic Oncology Research Group:
Primary Outcome Measures:
- Overall response rate [ Time Frame: 2 - 4 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity profile [ Time Frame: Toxicity assessment on each cycle ] [ Designated as safety issue: Yes ]
- Time to tumor progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 46 |
| Study Start Date: | March 2006 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024504
Locations
| Greece | |
| University General Hospital of Alexandroupolis, Dep of Medical Oncology | |
| Alexandroupolis, Greece | |
| IASO General Hospital of Athens, 1st Dep of Medical Oncology | |
| Athens, Greece | |
| Air Forces Military Hospital of Athens | |
| 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 | |
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
| Principal Investigator: | John Souglakos, MD | University Hospital of Crete, Dep of Medical Oncology |
| Principal Investigator: | Lampros Vamvakas, MD | University Hospital of Crete |
More Information
No publications provided
| Responsible Party: | John Souglakos, University Hospital of Crete |
| ClinicalTrials.gov Identifier: | NCT01024504 History of Changes |
| Other Study ID Numbers: | CT/06.12 |
| Study First Received: | November 26, 2009 |
| Last Updated: | April 8, 2010 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by Hellenic Oncology Research Group:
|
Cancer Colorectal cancer Elderly Chemotherapy |
Capecitabine Oxaliplatin Bevacizumab |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Oxaliplatin Capecitabine Bevacizumab |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013