Clinical trial NCT01024504: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Cancer
Colorectal cancer
Elderly
Chemotherapy
Capecitabine
Oxaliplatin
Bevacizumab
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2009-12-02
Enrollment: 46
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall response rate
timeFrame: 2 - 4 months
Secondary outcomes:
measure: Toxicity profile
timeFrame: Toxicity assessment on each cycle
measure: Time to tumor progression
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dep of Medical Oncology
city: Athens
country: Greece
facility: Air Forces Military Hospital of Athens
city: Athens
country: Greece
facility: IASO General Hospital of Athens, 1st Dep of Medical Oncology
city: Athens
country: Greece
facility: Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
city: Larissa
country: Greece
facility: State General Hospital of Larissa
city: Thessaloniki
country: Greece
facility: Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Study officials:
affiliation: University Hospital of Crete, Dep of Medical Oncology
name: John Souglakos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Crete
name: Lampros Vamvakas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.