Maintenance and Reinduction Chemotherapy With Avastin in Metastatic Colon Cancer: The MARTHA (SICOG 0803) Trial
- To compare two strategies of induction bio-chemotherapy followed by the same
maintenance biotherapy in terms of time to failure in patients with previously
untreated metastatic colorectal cancer.
- To compare the two arms of treatment in terms of response rate, duration of responses,
progression-free survival, safety, and quality of life of these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to treatment center,
performance status (0 vs 1), and number of metastatic sites (1 vs ≥ 2). Patients are
randomized to 1 of 2 induction therapy arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also
receive FOLFIRI chemotherapy comprising irinotecan hydrochloride IV over 1 hour and
leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46
hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses in the
absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive bevacizumab and FOLFIRI chemotherapy (B-FOLFIRI) as in arm I.
Treatment repeats every 2 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90
minutes on day 1 and oral capecitabine once every 12 hours on days 1-14. Treatment
repeats every 3 weeks for up to 4 courses in the absence of disease progression or
In both arms, patients achieving stable disease after completion of 6 months of induction
therapy proceed to maintenance therapy.
- Maintenance therapy: Patients receive bevacizumab IV over 30-90 minutes every 3 weeks
for up to 1 year in the absence of disease progression or unacceptable toxicity.
During or after completion of maintenance therapy, patients with tumor regrowth that is not
classified as disease progression from baseline and who achieved partial or complete
response during or after their induction therapy proceed to reinduction therapy.
- Reinduction therapy: Patients receive B-FOLFIRI as described previously. Quality of
life is assessed at baseline, every 3 months during induction therapy, and at
discontinuation of study therapy.
After completion of study therapy, patients are followed for up to 2 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Time to failure of strategy
Pasquale Comella, MD
Istituto Nazionale per lo Studio e la Cura dei Tumori