Vitamin D3 + Chemotherapy + Bevacizumab for Colorectal Cancer
(SOLARIS Trial)
Recruiting at 1061 trial locations
KN
JG
Overseen ByJun Gong
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Alliance for Clinical Trials in Oncology
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
This trial is testing if vitamin D3 along with regular cancer drugs and another drug that helps the immune system can better treat colorectal cancer that has spread. Vitamin D3 may help the body use essential minerals, making the cancer drugs more effective. Vitamin D3 has been shown to slow down cancer cell growth and help them mature, and it has been effective in reducing intestinal tumors in animal studies.
Research Team
KN
Kimmie Ng, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
This trial is for adults with advanced colorectal cancer that has spread, who haven't had treatment for metastatic disease. They should have finished any previous chemotherapy over a year ago and not be planning surgery to remove the cancer. Participants need measurable disease, no genetic mutations like dMMR or MSI-H, and can't have uncontrolled illnesses or be on certain medications.Inclusion Criteria
Urine protein to creatinine (UPC) ratio =< 1 mg/dL OR urine protein =< 1+
I have completed my rectal cancer radiation treatment more than 4 weeks ago.
My cancer does not have a known genetic mismatch repair issue.
See 34 more
Treatment Details
Interventions
- Bevacizumab (Angiogenesis Inhibitor)
- Cholecalciferol (Vitamin D)
- Fluorouracil (Chemotherapy)
- Irinotecan (Chemotherapy)
- Irinotecan Hydrochloride (Chemotherapy)
- Leucovorin Calcium (Chemotherapy)
Trial OverviewThe study tests if high-dose vitamin D3 combined with standard chemotherapy (leucovorin calcium, fluorouracil, oxaliplatin, irinotecan hydrochloride) and bevacizumab (a monoclonal antibody) improves outcomes in metastatic colorectal cancer compared to usual treatments.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (bevacizumab, chemotherapy, high-dose vitamin D3)Experimental Treatment9 Interventions
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV on days 1-3 or irinotecan hydrochloride IV on day 1, leucovorin calcium IV over 90 minutes on day 1, and fluorouracil IV on days 1-3. Patients also receive high-dose cholecalciferol PO QD on days 1-14. Cycles repeat every 14 days for 5 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (bevacizumab, chemotherapy, standard-dose vitamin D3)Active Control9 Interventions
Patients receive bevacizumab and chemotherapy as in Arm I. Patients also receive standard-dose cholecalciferol PO QD on days 1-14. Cycles repeat every 14 days for 5 years in the absence of disease progression or unacceptable toxicity.
Bevacizumab is already approved in Japan, Canada for the following indications:
Approved in Japan as Avastin for:
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
Approved in Canada as Avastin for:
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
Trials
521
Recruited
224,000+
National Cancer Institute (NCI)
Collaborator
Trials
14,080
Recruited
41,180,000+