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

• ClinicalTrials.gov Identifier: NCT01024504
• Recruitment Status: Completed
• First Posted: December 2, 2009
• Last Update Posted: April 9, 2010
• Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Information provided by: Hellenic Oncology Research Group

Tracking Information

• First Submitted Date: November 26, 2009
• First Posted Date: December 2, 2009
• Last Update Posted Date: April 9, 2010
• Study Start Date: March 2006
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 1, 2009): Overall response rate [ Time Frame: 2 - 4 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 1, 2009)

• Toxicity profile [ Time Frame: Toxicity assessment on each cycle ]
• Time to tumor progression [ Time Frame: 1 year ]
• Overall survival [ Time Frame: 1 year ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
• Official Title: A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
• 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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
  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

Study Arms

Experimental: XELOX/Avastin

Capecitabine Oxaliplatin Bevacizumab

Interventions:

• Drug: Oxaliplatin
• Drug: Capecitabine
• Drug: Bevacizumab

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: December 1, 2009): 46
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2010
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 70 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Greece

Administrative Information

• NCT Number: NCT01024504
• Other Study ID Numbers: CT/06.12
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: John Souglakos, University Hospital of Crete
• Study Sponsor: Hellenic Oncology Research Group
• Collaborators: 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

• PRS Account: Hellenic Oncology Research Group
• Verification Date: April 2010