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New treatment option for Stage, Colon Cancer
Official title Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases
ClinicalTrials.gov ID: NCT02172651
What this study is testing
What is Vitamin D3?
Vitamin D3 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for stage, colon cancer.
Also referred to as cholecalciferol (vitamin D3).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Participants must have histologically or cytologically confirmed adenocarcinoma of the colon with resectable liver metastases for which liver...
- 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.
You likely can't join if
- 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...
- Inability to swallow pills.
- History of malabsorption or uncontrolled vomiting or diarrhea, or any other disease significantly affecting gastrointestinal function that could...
See the full eligibility criteria
Who can 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...
- 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.
- 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 people 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...
- 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...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.