Vitamin D3 + Chemotherapy + Bevacizumab for Colorectal Cancer
(SOLARIS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether adding high doses of vitamin D3 to standard chemotherapy and bevacizumab can more effectively shrink or stabilize colorectal cancer that has spread. Vitamin D3 helps maintain strong bones, while bevacizumab, a type of immunotherapy, may assist the immune system in fighting cancer. The trial seeks to determine if this combination can extend the time patients live without disease progression compared to the usual treatment. Ideal participants have metastatic colorectal cancer, have not received systemic treatment for their condition, and are not taking high doses of vitamin D supplements. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. You must stop taking vitamin D supplements, thiazide diuretics (like hydrochlorothiazide), and some other medications like oral corticosteroids, lithium, phenytoin, quinidine, isoniazid, and rifampin at least 7 days before joining the trial. Check with the trial team for specific guidance on your medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that adding high-dose vitamin D3 to chemotherapy and bevacizumab is still under investigation for safety. Previous studies have found that vitamin D3 is usually safe with these treatments. However, high-dose vitamin D3 did not provide additional benefits in slowing cancer progression. No major safety issues were reported for either high-dose or standard-dose vitamin D3 when combined with chemotherapy and bevacizumab.
Bevacizumab, an FDA-approved drug for several cancer types, is generally well-tolerated. Chemotherapy drugs such as leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride have known side effects, which are managed as part of standard cancer care. The treatment combinations in the trial have been used before, and while side effects can occur, doctors usually monitor and manage them.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for colorectal cancer because they combine standard chemotherapy and bevacizumab with high-dose vitamin D3. Unlike typical treatments that don't include vitamin D, this approach explores how boosting vitamin D levels might enhance the effectiveness of cancer therapy. Vitamin D3 is thought to potentially improve cancer outcomes by supporting the immune system and inhibiting tumor growth. This dual approach allows scientists to investigate whether higher doses of vitamin D3 can provide added benefits over the standard dose, potentially leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for colorectal cancer?
Research has shown that adding vitamin D3 to chemotherapy and bevacizumab might help shrink or stabilize colorectal cancer. One study found that patients with higher vitamin D levels lived an average of 32.6 months, compared to 24.5 months for those with lower levels. In this trial, participants will receive either a high dose or a standard dose of vitamin D3 alongside chemotherapy and bevacizumab to determine if these doses can delay cancer progression. Recent findings suggest that a high dose of vitamin D3 does not significantly improve results compared to a standard dose. The effectiveness of these treatments is still under exploration, but early results are promising.13567
Who Is on the Research Team?
Kimmie Ng, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive chemotherapy, bevacizumab, and vitamin D3. Cycles repeat every 14 days for up to 5 years.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Cholecalciferol
- Fluorouracil
- Irinotecan
- Irinotecan Hydrochloride
- Leucovorin Calcium
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
- Colorectal cancer
- Breast cancer
- Non-small cell lung cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Glioblastoma
- Renal cell carcinoma
- Cervical cancer
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
- 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
National Cancer Institute (NCI)
Collaborator