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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

SOLARIS Trial Summary

This trial is testing whether giving vitamin D3 with standard chemo and bevacizumab helps treat colorectal cancer that has spread.

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.Check my eligibility
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.See study design
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.

SOLARIS Trial 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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I had chemotherapy or chemoradiation for colorectal cancer over a year ago.
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I have completed my rectal cancer radiation treatment more than 4 weeks ago.
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I haven't taken more than 2000 IU of vitamin D daily for a year before signing up.
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I had major surgery over 4 weeks ago or minor surgery over a week ago and have recovered.
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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 had chemotherapy or chemoradiation for colorectal cancer over a year ago.
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I completed my last radiation therapy for rectal cancer more than 4 weeks ago.
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I haven't taken more than 2000 IU of vitamin D daily for a year before signing up.
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I had major surgery over 4 weeks ago or minor surgery over a week ago and have recovered.
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I am not pregnant or breastfeeding, and if capable of becoming pregnant, I have a recent negative pregnancy test.
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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 have no active cancer except for non-melanoma skin cancer or cervical carcinoma in situ, and have been free of any other cancer for 3 years.
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I haven't had serious bleeding issues in the last 6 months.
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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 haven't had serious artery problems in the last 6 months.
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I do not have severe heart failure.
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I haven't had a GI perforation in the last year, except if it was due to colorectal cancer that's been removed.
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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.

SOLARIS Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
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
7%
Leg Cramps
7%
Viral Infection
7%
Hypercalcemia
7%
Allergic Infection
7%
Polydipsia
7%
Dehydration
7%
Urinary Tract Infection
3%
Chest Pain
3%
Sinusitis
3%
Headache
3%
General Infection
3%
Asthenia
3%
Fever
3%
Infection Fungal
3%
Conjuctivitis
3%
Syncope
3%
Depression
3%
Increased Cough
3%
Polyuria
3%
Abdominal Pain
3%
Photophobia
3%
Decreased libido
3%
Hypotension
3%
Nausea
3%
Esophageal ulcer
3%
Somnolence
3%
Back Pain
3%
Vomiting
3%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paricalcitol Treatment
Calcitriol Treatment
Cholecalciferol
Supplemental

SOLARIS 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
Bevacizumab
2013
Completed Phase 4
~5280
Oxaliplatin
2011
Completed Phase 4
~2560
Leucovorin Calcium
2011
Completed Phase 3
~12290
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Irinotecan
2017
Completed Phase 4
~2680
Cholecalciferol
2014
Completed Phase 4
~1100
Fluorouracil
2014
Completed Phase 3
~11540

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,179 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,913,529 Total Patients Enrolled
Kimmie Ng, MD, MPHStudy ChairDana-Farber Cancer Institute
2 Previous Clinical Trials
219 Total Patients Enrolled

Media Library

Bevacizumab (Angiogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04094688 — Phase 3
Colorectal Cancer Research Study Groups: Arm I (bevacizumab, chemotherapy, high-dose vitamin D3), Arm II (bevacizumab, chemotherapy, standard-dose vitamin D3)
Colorectal Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT04094688 — Phase 3
Bevacizumab (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04094688 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current vacancies for this type of medical research?

"The research indicates that this study is looking for patients. The original posting date was September 30th, 2019 and the latest update was on September 25th, 2022."

Answered by AI

Has the US Food and Drug Administration cleared Cholecalciferol for public consumption?

"There is some evidence to support the efficacy of Cholecalciferol, as this is a Phase 3 trial. Furthermore, there is data from multiple rounds supporting its safety; thus, we have given it a score of 3."

Answered by AI

Which medical condition is Cholecalciferol mostly prescribed for?

"Cholecalciferol is used to target a variety of cancerous growths, such as those found in the rectum, colon, and sarcoma. Additionally, this medication can be deployed against locally advanced stages of nonsquamous non-small cell lung cancer."

Answered by AI

Are there other investigations that have involved this vitamin D3 supplement?

"Cholecalciferol is being trialed in 969 clinical studies. Of these, 280 are Phase 3 trials. The vast majority of these medical trials are based in Guangzhou, Guangdong; however, there are a total of 42263 locations running Cholecalciferol trials."

Answered by AI

At how many hospitals is this research being conducted?

"There are 100 sites currently enrolling patients in this study. The locations of these clinics are listed on the website, and it is recommended that you select the one nearest to you to reduce travel time if you decide to participate."

Answered by AI

How many people are signing up to participate in this experiment?

"That is correct. As of September 25th, 2022, this clinical trial was still recruiting patients, 400 in total from 100 different locations around the world."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
California
How old are they?
18 - 65
What site did they apply to?
University of Alabama at Birmingham Cancer Center
Kaiser Permanente Medical Center - Santa Clara
University of Colorado Hospital
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Trying another place.
PatientReceived 1 prior treatment
~65 spots leftby Jan 2025