Colorectal Cancer Metastatic Clinical Trial
Official title:
Maintenance Treatment With Capecitabine and Bevacizumab Versus Observation After Induction Treatment With Chemotherapy and Bevacizumab as First-line Treatment in Patients With Advanced Colorectal Carcinoma
The optimal duration of systemic treatment in patients with advanced colorectal cancer is
unknown.
In this study the effects of bevacizumab and low-dose continuous chemotherapy with
capecitabine is investigated in patients who have responded to 6 courses of oxaliplatin,
capecitabine and bevacizumab ("induction treatment", at standard doses). This treatment is
continued until progression or severe toxicity. This regimen is compared to the effects a
observation without treatment after the induction treatment.
In case of disease progression, induction treatment will be reintroduced.
Standard 1st-line treatment for patients with advanced colorectal cancer currently consists
of chemotherapy plus bevacizumab. With this approach the median overall survival is
approximately 20 months, and progression-free survival in first-line approximately 9-11
months. The optimal duration of treatment is unknown. Current data suggest that the efficacy
of bevacizumab is dependent on concomitant use of chemotherapy. However, oxaliplatin almost
invariably gives rise to neuropathy after 6-8 cycles. Prolonged use of capecitabine is
associated with e.g. hand-foot syndrome. Lastly, the prolonged use of these agents is
associated with considerable costs.
Evidence, mainly preclinical, suggests that continuous dosing metronomic chemotherapy may be
more efficacious than interval-chemotherapy given at MTD. In this study the concept of
metronomic chemotherapy is explored by administering a continuous daily instead of the usual
2 weeks-on/1 week-off oral dosing regimen of low-dose capecitabine plus bevacizumab as
maintenance therapy after induction combination chemotherapy given at MTD plus bevacizumab.
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