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Stage, Colon CancerEarly Phase 1NCT02172651

Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases

A Early Phase 1 study testing Vitamin D3 in people with Stage, Colon Cancer and Stage I-III Colon Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study seeks to learn more about the vitamin D receptor and its relationship to colon cancer. The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the receptor in the cancer cells, it may stop cancer cells from growing abnormally and may cause cancer cell death. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vitamin D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteUnited States
Study dates
14 Jul 2014to 30 Jun 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet the following criteria on screening examination to be eligible to participate in the study:
  • Participants must have histologically confirmed adenocarcinoma of the colon that is localized, with no evidence of distant metastasis (stage I, II, or III), and for which surgical resection of the primary tumor is being planned;
  • --OR
  • Participants must have histologically or cytologically confirmed adenocarcinoma of the colon with resectable liver metastases for which liver resection is being planned.
  • No prior radiation therapy or systemic treatment is allowed for patients undergoing resection of stage I, II, or III colon cancer.
  • Prior systemic treatment or radiation therapy is allowed for patients with resectable liver metastases.
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  • The last dose of chemotherapy or radiation must have been administered at least 4 weeks prior to liver surgery.
  • The last dose of bevacizumab must have been administered at least 6 weeks prior to liver resection.
  • Age ≥18 years.
  • ECOG performance status ≤ 1 (see Appendix A)
  • Participants must have normal organ and marrow function as defined below:
  • Total bilirubin ≤1.5× institutional upper limit of normal (ULN)
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN, or <5x ULN if clearly attributable to liver metastases
  • Serum calcium (corrected for albumin level) ≤ 1x institutional ULN
  • Serum creatinine within normal institutional limits or creatinine clearance ≥60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
  • Participants on full-dose anticoagulation are eligible if the following criteria are met:
  • Participant has an in-range INR (usually 2-3) on a stable dose of warfarin or is on a stable dose of low molecular weight heparin
  • Participant has no active bleeding or pathological condition that carries a high risk of bleeding (i.e., tumor involving major vessels or known varices)
  • Participants receiving anti-platelet agents are eligible. In addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible.
  • Discontinuation of anticoagulation, aspirin, and/or anti-platelet agents prior to surgery will occur according to institutional standards of care.
  • Non-pregnant and not nursing
  • Women of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 14 days prior to study entry. Women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level >35 mIU/mL). Women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who are practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child-bearing potential.
  • The effects of higher-dose vitamin D3 and colon or liver surgery (and associated perioperative medications and anesthesia) on the developing human fetus are unknown and may pose unacceptable risk. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
  • Prior systemic therapy, radiotherapy, or investigational agent in participants undergoing surgery for stage I, II, or III colon cancer.
  • Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for bevacizumab) of liver resection.
  • Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol.
  • Inability to swallow pills.
  • History of malabsorption or uncontrolled vomiting or diarrhea, or any other disease significantly affecting gastrointestinal function that could interfere with absorption of oral medications.
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  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to vitamin D.
  • Regular use of supplemental vitamin D totaling ≥ 2,000 IU/day in the past year.
  • Use of supplemental vitamin D or supplements containing vitamin D beyond the protocol-prescribed study treatment is not allowed during the treatment period of this clinical trial.
  • In order to maintain blinding, vitamin D levels should not be routinely checked at screening or during the study by the treating investigator. Vitamin D levels will be assayed only as part of the research blood samples collected during the study. If there are concerns related to a participant's vitamin D status, the lead Principal Investigator should be contacted for further discussion.
  • Use of chronic oral corticosteroid therapy, lithium, phenytoin, quinidine, isoniazid, and/or rifampin (all of which can cause vitamin D depletion). Short-term use of corticosteroids as anti-emetic therapy for chemotherapy is permitted.
  • Regular use of thiazide diuretics (i.e., hydrochlorothiazide), which can lead to hypercalcemia, and unwillingness or inability to discontinue or switch to an alternative anti-hypertensive agent.
  • Pre-existing hypercalcemia (defined as baseline serum calcium above the institutional ULN, corrected for albumin level if albumin is not within institutional limits of normal).
  • -- The use of supplemental calcium or supplements containing calcium is prohibited during the treatment period of this clinical trial.
  • Known active hyperparathyroid disease or other serious disturbance of calcium metabolism in the past 5 years.
  • History of symptomatic genitourinary stones within the past year.
  • Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, limit compliance with study requirements, or interfere with the interpretation of study results.
  • Pregnant or nursing women or men/women of child-bearing potential who are unwilling to employ adequate contraception.
  • -- Pregnant and nursing women are excluded from this study because there is an unknown but potential risk of adverse events related to higher-dose vitamin D3 and colon or liver surgery (and associated perioperative medications and anesthesia) on the human fetus. Consequently, breastfeeding should be discontinued if the mother is enrolled on the study.
  • History of prior or synchronous malignancy except:
  • A malignancy that was treated with curative intent, for which there has been no known active disease for >3 years prior to randomization, and for which the risk of recurrence is low as determined by the investigator.
  • Curatively treated non-melanoma skin malignancy, cervical cancer in situ, or prostatic intraepithelial neoplasia without evidence of prostate cancer.
  • Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.
  • Participants with these infections are ineligible because they are at increased risk of significant complications in the perioperative period, particularly for active hepatitis B or C patients undergoing liver resection. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kimmie Ng, MD contact

617-632-5960

United States1 site, 1 recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

    Kimmie Ng, MD, 617-632-5960

    Kimmie Ng, MD, MPH

    Recruiting

Other trials in United States

About this study

Official title: Study to Identify Transcriptional Targets of Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases Receiving Preoperative Vitamin D Supplementation.

This study seeks to learn more about the vitamin D receptor and its relationship to colon cancer. The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the receptor in the cancer cells, it may stop cancer cells from growing abnormally and may cause cancer cell death. Vitamin D has been used in other research studies and information from those other research studies suggests that Vitamin D may help in the treatment of colon cancer.

Participants will receive either high-dose vitamin D or standard-dose vitamin D. The study drug will be given 14-28 days prior to your surgery. The number of days will depend on when the surgery is scheduled.

Read the detailed description

The participant will be given a study drug-dosing diary to keep track of when they take the study drug. The participant will be taking the study drug once every day, for 14 - 28 days, prior to their surgery.

  • Run-In Phase: The first 6-12 participants will receive high-dose vitamin D prior to surgery. The number of participants in this phase will be based on the results of the analyzed research samples.
  • Randomized Phase: Because no one knows which of the study options is best, the participant will be "randomized" into one of the study groups: high dose vitamin D or standard dose vitamin D.
  • 48 Participants will be randomized to receive high-dose vitamin D or standard-dose vitamin D. Randomization means that the participants are put into a group by chance. Neither the participant nor the research doctor will choose what group the participant will be in. The participant will have an equal chance of getting assigned to each arm (like flipping a coin). The randomized phase will enroll to two groups at the same time:
  • Group A: 24 participants with a recent diagnosis of stage I, II or III colon cancer will be randomized to receive high-dose vitamin D or standard-dose vitamin D.
  • Group B: 24 participants with resectable liver metastases from colon cancer will be randomized to receive high-dose vitamin D or standard-dose vitamin D.

Additional research procedures to be performed on study:

  • Blood samples will be collected for research purposes (a little more than 2 teaspoons of blood). The samples will be collected immediately prior to the participant's surgery and used to study the vitamin D receptor and pathway, as well as its relationship to colon cancer. Some of this blood will be stored to be used for future cancer research.
  • Tumor tissue will be collected for research purposes at the time of the participant surgery. This tissue will also be used to study the vitamin D receptor and pathway, as well as its relationship to colon cancer. Some of the tumor tissue collected will be sent for use in a separate, but related study. In this study, the participant's tumor will be used to grow cell lines. This means the participant's tumor cells will be multiplied in the lab. These cell lines will be used to study the binding sites in the genes of participants and learn more about vitamin D's role in preventing colon cancer.
Being tested
Vitamin D3, Placebo
Keywords
Vitamin D, Stage I-III colon cancer, Stage IV colon cancer, Resectable liver metastases
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3Drug

    Also called cholecalciferol (vitamin D3)

    Take five 10,000 IU capsules (total 50,000 IU) once daily for 7 days, followed by one 10,000 IU capsule once daily until surgery.

  • PlaceboDrug

    Take five placebo capsules once daily for 7 days, followed by one placebo capsule once daily until surgery.

Study groups in NCT02172651
Study groupRoleWhat they receive
Vitamin D3 - Blinded RegistrationExperimentalOne capsule of vitamin D3 10,000 IU orally once daily for 14 days until the date of surgery. To allow for some flexibility in the scheduling of surgery, patients can be treated with preoperative vitamin D3 for up to 28 days. On the morning of surgery, prior to operating, a second blood sample will be collected for follow-up 25(OH)D, calcium, and albumin determination. Colon and liver resection will occur per institutional standards of care, and malignant and adjacent benign tissue will be collected for the laboratory endpoints described in this protocol.
Receives: Drug: Vitamin D3
Placebo - Blinded RegistrationPlacebo comparatorOne placebo capsule orally once daily for 14 days until the date of surgery. To allow for some flexibility in the scheduling of surgery, patients can be treated with preoperative placebo for up to 28 days. On the morning of surgery, prior to operating, a second blood sample will be collected for follow-up 25(OH)D, calcium, and albumin determination. Colon and liver resection will occur per institutional standards of care, and malignant and adjacent benign tissue will be collected for the laboratory endpoints described in this protocol.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VDR Binding Sites

    For patients undergoing primary colon resection, the goal is to identify VDR binding sites in malignant and normal colonic tissue collected from colon cancer patients treated with high-dose vitamin D3 versus placebo.

    ChIP-Seq will be performed on frozen tumor tissue and adjacent normal colon tissue to determine VDR binding sites, which will be compared between the high-dose vitamin D and placebo arms, and between malignant tumor and normal colon tissue.

    Measured: 14 to 28 days

Secondary outcomes (2)

  1. Changes in TME

    For patients undergoing liver resection, the goal is to characterize changes in the TME of liver metastases collected from colon cancer patients treated with high-dose vitamin D3 versus placebo.

    Tumor microarrays will be constructed from FFPE tissue to evaluate the densities and co-localization of TILs and other immune cell types with tumor epithelial cells using custom multiplex immunofluorescence assays with supervised machine learning. A custom vitamin D-immune panel will also be used to measure nuclear VDR and cytoplasmic CYP27B1 expression at the single cell level in pan-CK+ tumor epithelial cells, numerous immune cell populations (CD3+CD4+ T helper cells, CD3+CD8+ cytotoxic T cells, CD68/CD163+ macrophages, CD45+ total immune cells), and pan-CK-/CD45- stromal cells.

    Measured: 14 to 28 days

  2. Number of Participants with Serious and Non-Serious Adverse Events

    Grade of severity in accordance with the NCI-CTCAE version 4.0 guideline

    Measured: Baseline, 14 days to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2014 (estimated)
  2. Study start14 Jul 2014
  3. Primary completion15 Apr 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02172651
Sponsor's protocol ID
14-091
Other IDs
P50CA127003-06A1
Status last verified
May 2026
First submitted
17 Jun 2014
Last updated
13 May 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Vitamin D3 in people with Stage, Colon Cancer and Stage I-III Colon Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kimmie Ng, MD (617-632-5960), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VDR Binding Sites (time frame: 14 to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02172651.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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