Status:
TERMINATED
High-Dose Cholecalciferol in Treating Patients Receiving Combination Chemotherapy and Bevacizumab as First-Line Therapy For Metastatic Colorectal Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage IV Colon Cancer
Stage IV Rectal Cancer
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving high-dose cholecalciferol works in treating patients receiving combination chemotherapy and bevacizumab as first-line therapy for metastatic colorectal ...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the relative rate of metastatic colorectal cancer patients who achieve 25-D3 levels \>= 40 ng/ml at 8 weeks, 16 weeks, 24 weeks, and 32 weeks from starting FOLFOX ...
Eligibility Criteria
Inclusion
- Patients should have untreated metastatic colorectal cancer; prior adjuvant chemotherapy is allowed as long as the development of metastatic disease occurred more than 6 months from completion of adjuvant treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Platelets \>= 100,000/mm\^3
- Absolute neutrophil count (ANC) \>= 1,500/mm\^3
- Hemoglobin \> 9 gm/dl
- Calculated creatinine clearance \> 40 ml/min according to the Cockcroft-Gault formula OR per 24 hour urine collection
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 x institutional upper normal level if no liver metastases and \< 5 x upper limit of normal (ULN) in the setting of liver metastases
- Total bilirubin =\< 1.5 x institutional upper normal level
- Albumin \>= 2.5 g/dl
- Urine protein:creatinine (UPC) ratio \< 1; in the event UPC is \> 1, the patient will require a 24-hr urine protein and will be eligible if 24-hr urine collection has \< 1,000 mg protein
- Patients of child-hearing potential must agree to use acceptable contraceptive methods (e.g., double harrier) during treatment
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form prior to receiving any study-related procedure
- Presence of measurable disease defined as a lesion \>= 1 cm by computed tomography (CT); all sites of disease should be evaluated =\< 3 weeks before treatment initiation
- Baseline 25-D3 level of \< 40 ng/ml
Exclusion
- Patients may not be receiving any other investigational agents that are not included in this study
- Patients with known brain metastases
- History of other invasive cancers with the exception of the following: a. Curatively resected or treated non-melanoma skin cancer; b. Curatively treated cervical carcinoma in situ; c. Other primary solid tumors treated curatively and no treatment administered \>= 2 years before enrollment, and in the investigator opinion, it is unlikely that there will be a recurrence =\< 1 year post enrollment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, 5-FU, leucovorin, bevacizumab, and vitamin D3 and other agents used in study
- History of clinically significant bleeding within 6 months of enrollment
- Clinically significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated on this study
- Major surgery within 28 days prior to enrollment or still recovering from prior surgery
- Known dihydropyrimidine dehydrogenase (DpD) deficiency
- History or evidence upon physical examination of central nervous system (CNS) disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)
- Serious, nonhealing wound, ulcer, or bone fracture
- Uncontrolled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 95 mmHg despite medications)
- History of arterial thrombosis within the last 12 months
- History of visceral arterial ischemia
- Subjects unwilling or unable to comply with study requirements
- Any condition that in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
- Received an investigational agent within 30 clays prior to enrollment
- Treatment with vitamin D replacement with doses exceeding an average of 1000 IU/day (vitamin D3) within 60 days prior to enrollment
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01198548
Start Date
August 1 2010
End Date
June 1 2012
Last Update
July 21 2014
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263