Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases
- Conditions
- Stage, Colon CancerStage I-III Colon CancerStage IV Colon Cancer With Resectable Liver Metastases
- Registration Number
- NCT02172651
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>Participants must meet the following criteria on screening examination to be eligible to<br>participate in the study:<br><br> - Participants must have histologically confirmed adenocarcinoma of the colon that is<br> localized, with no evidence of distant metastasis (stage I, II, or III), and for<br> which surgical resection of the primary tumor is being planned;<br><br> --OR<br><br> - Participants must have histologically or cytologically confirmed adenocarcinoma of<br> the colon with resectable liver metastases for which liver resection is being<br> planned.<br><br> - No prior radiation therapy or systemic treatment is allowed for patients undergoing<br> resection of stage I, II, or III colon cancer.<br><br> - Prior systemic treatment or radiation therapy is allowed for patients with<br> resectable liver metastases.<br><br> - The last dose of chemotherapy or radiation must have been administered at least<br> 4 weeks prior to liver surgery.<br><br> - The last dose of bevacizumab must have been administered at least 6 weeks prior<br> to liver resection.<br><br> - Age =18 years.<br><br> - ECOG performance status = 1 (see Appendix A)<br><br> - Participants must have normal organ and marrow function as defined below:<br><br> - Total bilirubin =1.5× institutional upper limit of normal (ULN)<br><br> - AST(SGOT)/ALT(SGPT) = 2.5 × institutional ULN, or <5x ULN if clearly<br> attributable to liver metastases<br><br> - Serum calcium (corrected for albumin level) = 1x institutional ULN<br><br> - Serum creatinine within normal institutional limits or creatinine clearance =60<br> mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.<br><br> - Participants on full-dose anticoagulation are eligible if the following criteria are<br> met:<br><br> - Participant has an in-range INR (usually 2-3) on a stable dose of warfarin or<br> is on a stable dose of low molecular weight heparin<br><br> - Participant has no active bleeding or pathological condition that carries a<br> high risk of bleeding (i.e., tumor involving major vessels or known varices)<br><br> - Participants receiving anti-platelet agents are eligible. In addition, patients<br> who are on daily prophylactic aspirin or anticoagulation for atrial<br> fibrillation are eligible.<br><br> - Discontinuation of anticoagulation, aspirin, and/or anti-platelet agents prior<br> to surgery will occur according to institutional standards of care.<br><br> - Non-pregnant and not nursing<br><br> - Women of child-bearing potential must have a negative serum or urine pregnancy<br> test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 14 days<br> prior to study entry. Women of child-bearing potential include any female who<br> has experienced menarche and who has not undergone surgical sterilization<br> (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not<br> postmenopausal (defined as amenorrhea =12 consecutive months; or women on<br> hormone replacement therapy with documented serum follicle stimulating hormone<br> level >35 mIU/mL). Women who are using oral, implanted, or injectable<br> contraceptive hormones or mechanical products such as intrauterine device or<br> barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who<br> are practicing abstinence or where partner is sterile (e.g., vasectomy), should<br> be considered to be of child-bearing potential.<br><br> - The effects of higher-dose vitamin D3 and colon or liver surgery (and<br> associated perioperative medications and anesthesia) on the developing human<br> fetus are unknown and may pose unacceptable risk. For this reason, women of<br> child-bearing potential and men must agree to use adequate contraception<br> (hormonal or barrier method of birth control; abstinence) prior to study entry<br> and for the duration of study participation. Should a woman become pregnant or<br> suspect she is pregnant while participating in this study, she should inform<br> her treating physician immediately.<br><br> - Ability to understand and the willingness to sign a written informed consent<br> document.<br><br>Exclusion Criteria:<br><br>Participants who exhibit any of the following conditions at screening will not be<br>eligible for admission into the study.<br><br> - Prior systemic therapy, radiotherapy, or investigational agent in participants<br> undergoing surgery for stage I, II, or III colon cancer.<br><br> - Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for<br> bevacizumab) of liver resection.<br><br> - Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted<br> agents, biological agents, immunotherapy, or investigational agents not otherwise<br> specified in this protocol.<br><br> - Inability to swallow pills.<br><br> - History of malabsorption or uncontrolled vomiting or diarrhea, or any other disease<br> significantly affecting gastrointestinal function that could interfere with<br> absorption of oral medications.<br><br> - History of allergic reactions attributed to compounds of similar chemical or<br> biologic composition to vitamin D.<br><br> - Regular use of supplemental vitamin D totaling = 2,000 IU/day in the past year.<br><br> - Use of supplemental vitamin D or supplements containing vitamin D beyond the<br> protocol-prescribed study treatment is not allowed during the treatment period<br> of this clinical trial.<br><br> - In order to maintain blinding, vitamin D levels should not be routinely checked<br> at screening or during the study by the treating investigator. Vitamin D levels<br> will be assayed only as part of the research blood samples collected during the<br> study. If there are concerns related to a participant's vitamin D status, the<br> lead Principal Investigator should be contacted for further discussion.<br><br> - Use of chronic oral corticosteroid therapy, lithium, phenytoin, quinidine,<br> isoniazid, and/or rifampin (all of which can cause vitamin D depletion). Short-term<br> use of corticosteroids as anti-emetic therapy for chemotherapy is permitted.<br><br> - Regular use of thiazide diuretics (i.e., hydrochlorothiazide), which can lead to<br> hypercalcemia, and unwillingness or inability to discontinue or switch to an<br> alternative anti-hypertensive agent.<br><br> - Pre-existing hypercalcemia (defined as baseline serum calcium above the<br> institutional ULN, corrected for albumin level if albumin is not within<br> institutional limits of normal).<br><br> -- The use of supplemental calcium or supplements containing calcium is prohibited<br> during the treatment period of this clinical trial.<br><br> - Known active hyperparathyroid disease or other serious disturbance of calcium<br> metabolism in the past 5 years.<br><br> - History of symptomatic genitourinary stones within the past year.<br><br> - Any uncontrolled intercurrent illness including, but not limited to, ongoing or<br> active infection, symptomatic congestive heart failure, unstable angina pectoris,<br> cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of<br> the investigator, may increase the risks associated with study participation or<br> study treatment, limit compliance with study
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VDR Binding Sites
- Secondary Outcome Measures
Name Time Method Changes in TME;Number of Participants with Serious and Non-Serious Adverse Events