Vitamin D3 + Chemotherapy + Bevacizumab for Colorectal Cancer
(SOLARIS Trial)
Recruiting at 1061 trial locations
KN
JG
Overseen ByJun Gong
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Alliance for Clinical Trials in Oncology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
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.
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Treatment Details
Interventions
- Bevacizumab
- Cholecalciferol
- Fluorouracil
- Irinotecan
- Irinotecan Hydrochloride
- Leucovorin Calcium
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 European Union, United States, Japan, Canada for the following indications:
Approved in European Union as Avastin for:
- Colorectal cancer
- Breast cancer
- Non-small cell lung cancer
- Renal cell carcinoma
- Ovarian cancer
Approved in United States as Avastin for:
- Colorectal cancer
- Non-small cell lung cancer
- Glioblastoma
- Renal cell carcinoma
- Cervical cancer
- Ovarian cancer
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+
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