Autophagy and Anti-Angiogenesis in Metastatic Colorectal Carcinoma: A Phase II Trial of Hydroxychloroquine to Augment Effectiveness of XELOX-Bevacizumab. A Study of the Cancer Institute of New Jersey Oncology Group (CINJOG)
- To assess the progression-free survival (PFS) of patients with metastatic colorectal
carcinoma treated with hydroxychloroquine in combination with capecitabine,
oxaliplatin, and bevacizumab and to compare this to a previously reported median PFS of
- To measure the overall response rate.
- To measure the duration of response for responding patients.
- To measure the disease-control rate (complete response, partial response, or stable
disease for at least 2 courses).
- To document the safety and feasibility of this regimen in these patients.
- To develop surrogate biomarkers for autophagy detection in patient tissue specimens and
to characterize the effects of hydroxychloroquine on autophagy in patients in vivo.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1.
Patients also receive oral capecitabine twice daily on days 1-15 and oral hydroxychloroquine
twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression
or unacceptable toxicity.
Peripheral blood and tumor tissue samples may be collected for biomarker and other
After completion of study treatment, patients are followed up for 1 year.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Rebecca A. Moss, MD
Cancer Institute of New Jersey
United States: Institutional Review Board
|Cancer Institute of New Jersey at Hamilton||Hamilton, New Jersey 08690|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|
|New Jersey Medical School/The University Hospital Cancer Center||Newark, New Jersey 07103|