Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS).
This phase III trial studies how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving vitamin D3 with chemotherapy and bevacizumab may work better in shrinking or stabilizing colorectal cancer. It is not yet known whether giving high-dose vitamin D3 in addition to chemotherapy and bevacizumab would extend patients' time without disease compared to the usual approach (chemotherapy and bevacizumab).
• Histologically confirmed advanced/metastatic colorectal adenocarcinoma for which metastasectomy is not planned.
• No prior systemic treatment for metastatic disease.
• Patients may have received prior neoadjuvant or adjuvant chemotherapy and/or chemoradiation. The last course of adjuvant therapy must have been completed greater than 12 months prior to colorectal cancer recurrence.
• Patients may have received prior standard rectal cancer chemoradiation so long as prior radiotherapy was to less than or equal to 25% of bone marrow. Previous radiation therapy must have been completed in greater than or equal to 4 weeks prior to registration.
• No continuous daily use of vitamin D supplements greater than or equal to 2,000 IU per day for the 12 months prior to registration. Patients may have had continuous daily use of vitamin D supplements greater than or equal to 2,000 IU per day if total duration less than 12 months in the 12 months prior to registration. Patients may have had continuous daily use of vitamin D supplements less than 2,000 IU per day for any duration prior to registration.
Alison Conlin, M.D.
The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.