Front-line Combination Therapy of Sunitinib Malate Plus Chemotherapy With Leucovorin/5-Fluorouracil and Irinotecan (FOLFIRI) for Rectal Cancer Patients With Synchronous Non-Resectable Metastases: A Phase II Non Controlled Study. (SUREMETS)
- Evaluation of the efficacy of front-line treatment with sunitinib malate and FOLFIRI
chemotherapy at 3 months in patients with rectal cancer and synchronous metastases
deemed unresectable in a multidisciplinary consultation.
- Evaluate the rate of resection of secondary metastases and rectal cancer, rate of R0
resection of metastases and rectal cancer, and the rate of complete response after
- Evaluate the rate of local failure (progression of rectal cancer).
- Evaluate the rate of local complications.
- Evaluate disease-free survival.
- Evaluate progression-free survival, metastatic progression-free survival, and local
- Evaluate symptom-free survival.
- Evaluate overall survival.
- Evaluate quality of life, specifically fatigue and global health score (EORTC QLQ-C30).
- Evaluate the tolerance to treatment.
- Conduct translational research, in particular, pharmacokinetic studies of plasma and
rectal tumor biopsies, and histological and molecular studies.
OUTLINE: Patients receive simplified FOLFIRI chemotherapy comprising irinotecan
hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV
over 46 hours on days 1, 15, and 29. Patients also receive oral sunitinib malate once daily
on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or
Patients may undergo surgical resection and/or local radiotherapy if the tumor regresses.
After resection or radiotherapy, patients may undergo up to 4 more courses of study
Biopsies of the tumor and healthy mucosa are collected for translational research at
baseline. Blood samples are collected for pharmacodynamic and pharmacogenetic studies at
baseline and at week 6. Patients also complete a quality-of-life questionnaire (EORTC
QLQ-C30) at baseline and periodically thereafter.
After completion of study therapy, patients are followed up every 12 weeks.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Response rate at 3 months as assessed by RECIST criteria
Philippe Rougier, MD
Hopital Ambroise Pare