What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as chemotherapy (leucovorin calcium, fluorouracil, oxaliplatin, irinotecan hydrochloride) and immunotherapy (bevacizumab), have side effects including nausea, vomiting, diarrhea, fatigue, hair loss, and increased infection risk. Bevacizumab specifically can cause hypertension, bleeding, clotting issues, and gastrointestinal perforations. High-dose Vitamin D3, which enhances calcium and phosphorus utilization, can cause hypercalcemia, leading to nausea, vomiting, weakness, and kidney complications. Combining these treatments aims to improve efficacy but may also increase the likelihood of compounded side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer, including chemotherapy agents such as leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride. These drugs work by killing cancer cells, stopping their division, or preventing their spread. Additionally, bevacizumab, an immunotherapy agent, has been approved to help the immune system attack cancer and inhibit tumor growth. These treatments are often used in combination to enhance efficacy, similar to the approach being studied with high-dose Vitamin D3 to potentially improve outcomes by enhancing calcium and phosphorus utilization.

What other types of research exist?

Promising novel alternatives to high-dose Vitamin D3 for colorectal cancer patients include immunotherapy agents such as checkpoint inhibitors (e.g., pembrolizumab, nivolumab), targeted therapies (e.g., BRAF inhibitors for BRAF-mutant tumors), and combination therapies involving chemotherapy with novel agents like PARP inhibitors or anti-angiogenic drugs (e.g., ramucirumab). These alternatives aim to enhance the efficacy of standard treatments and improve patient outcomes.

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Angiogenesis Inhibitor

Vitamin D3 + Chemotherapy + Bevacizumab for Colorectal Cancer (SOLARIS Trial)

Phase 3

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No known mismatch repair deficiency (dMMR) or high-frequency microsatellite instability (MSI-H) disease.

No prior systemic treatment for metastatic disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects include bone pain or muscle problems from vitamin D3; bleeding, hypertension, wound healing complications from bevacizumab; and typical chemo side effects like nausea, fatigue, hair loss, nerve damage and increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer does not have a known mismatch repair deficiency or high microsatellite instability.

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I have not had any drug treatments for cancer that has spread.

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My colorectal cancer has spread, and surgery to remove the spread is not planned.

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My cancer does not have a known genetic mismatch repair issue.

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I haven't had any treatment for cancer that has spread.

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I am fully active or can carry out light work.

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

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I do not have plans for surgery to remove cancer that has spread.

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I haven't had a stroke, heart attack, or severe angina in the last 6 months.

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I do not have severe heart failure.

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I don't have any conditions that badly affect my stomach or intestines.

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I do not have any serious wounds, ulcers, or unhealed bone fractures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

25(OH)D levels

Incidence of adverse events

Incidence of vitamin D3 deficiency

+4 more

Side effects data

From 2010 Phase 4 trial • 109 Patients • NCT01265615

23%

Hypophospatemia

17%

Fatigue

13%

Increased hypertension

13%

Edema

13%

Diarrhea

13%

Pain

10%

Taste perversions

10%

Arthritis

10%

Dizziness

10%

Gastroenteritis

10%

Vertigo

10%

Rhinitis

10%

Bronchitis

10%

Rash

Leg Cramps

Viral Infection

Hypercalcemia

Allergic Infection

Polydipsia

Dehydration

Urinary Tract Infection

Chest Pain

Sinusitis

Headache

General Infection

Asthenia

Fever

Infection Fungal

Conjuctivitis

Syncope

Depression

Increased Cough

Polyuria

Abdominal Pain

Photophobia

Decreased libido

Hypotension

Nausea

Esophageal ulcer

Somnolence

Back Pain

Vomiting

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

Paricalcitol Treatment

Calcitriol Treatment

Cholecalciferol

Supplemental

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leucovorin Calcium

2011

Completed Phase 3

~12500

Irinotecan Hydrochloride

2010

Completed Phase 3

~2050

Oxaliplatin

2011

Completed Phase 4

~2890

Bevacizumab

2013

Completed Phase 4

~5540

Irinotecan

2017

Completed Phase 3

~2590

Cholecalciferol

2014

Completed Phase 4

~1100

Fluorouracil

2014

Completed Phase 3

~11700

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer include chemotherapy, immunotherapy, and potentially high-dose Vitamin D3. Chemotherapy drugs like leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride kill cancer cells, inhibit their division, or prevent their spread. Immunotherapy, such as bevacizumab, boosts the immune system's ability to attack cancer cells and inhibits tumor growth. High-dose Vitamin D3 enhances calcium and phosphorus utilization, which may improve the effectiveness of chemotherapy and immunotherapy. This combination is being studied to see if it can better shrink or stabilize colorectal cancer, potentially extending the time patients remain disease-free.

K-ras mutations in 1,2-dimethylhydrazine-induced colonic tumors: effects of supplemental dietary calcium and vitamin D deficiency.A randomized clinical trial of the effects of supplemental calcium and vitamin D3 on the APC/β-catenin pathway in the normal mucosa of colorectal adenoma patients.A protective role of dietary vitamin D3 in rat colon carcinogenesis.