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1st Line Chemotherapy Alone or With Bevacizumab in Treating Older Patients With Metastatic Colorectal Cancer

CompletedPhase 2

Sponsor: Federation Francophone de Cancerologie Digestive

Conditions: Colorectal Cancer

Interventions: Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen), Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) + bevacizumab

Countries: France

RATIONALE: Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving bevacizumab together with combination chemotherapy may be a better way to block tumor growth. It is not yet known whether combination chemotherapy is more effective when given together with or without bevacizumab in treating patients with colorectal cancer. PURPOSE: This randomized phase II trial is studying the side effects of giving bevacizumab together with first-line chemotherapy and to see how well it works in treating older patients with metastatic colorectal cancer.

Eligibility overview

Sex: ALL

Age: 75 Years to 120 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic colorectal adenocarcinoma

  * Unresectable disease
* Measurable disease by RECIST criteria
* No cerebral metastasis

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* Polynuclear neutrophils \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Proteinuria ≤ 1 g on 24-hour urine collection
* No unresolved intestinal occlusion or subocclusion
* No other progressive or unstabilized malignant tumor within the past 2 years
* No progressive gastroduodenal ulcer, wound, or bone fracture
* No active cardiac disease including any of the following:

  * Hypertension not adequately controlled
  * Myocardial infarction within the past 6 months
  * Poorly controlled angina
  * Decompensated congestive cardiac insufficiency
* No history of arterial thromboembolism or any of the following within the past 12 months:

  * Cerebrovascular accident
  * Transient ischemic attack
  * Subarachnoid hemorrhage
* No history of distal or visceral ischemic arterial pathology ≥ grade 2 within the past 12 months
* No history of life-threatening pulmonary embolism within the past 6 months
* Must have completed the geriatric self-administered questionnaire and the geriatric "team" questionnaire (including the Spitzer QoL Index)

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy for metastatic disease

  * More than 6 months since adjuvant chemotherapy after resection of the primary tumor
* More than 4 weeks since major surgery, excluding biopsy
* More than 4 weeks since radiotherapy

Locations (1)

Bobigny, France