Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Active, not recruiting Phase 3

Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer

NCT04094688 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 3
Started
2019-10-29
Last updated
2026-10-14

Condition(s) studied

Colorectal Adenocarcinoma

Investigational drug(s) / intervention(s)

Bevacizumab →Oxaliplatin →Leucovorin Calcium →Fluorouracil →Irinotecan Hydrochloride →Irinotecan →CholecalciferolQuality-of-Life AssessmentQuestionnaire Administration

Bevacizumab: Given IV

Oxaliplatin: Given IV

Leucovorin Calcium: Given IV

Fluorouracil: Given IV

Irinotecan Hydrochloride: Given IV

Irinotecan: Given IV

Cholecalciferol: Given PO

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Study summary

This phase III trial studies how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving vitamin D3 with chemotherapy and bevacizumab may work better in shrinking or stabilizing colorectal cancer. It is not yet known whether giving high-dose vitamin D3 in addition to chemotherapy and bevacizumab would extend patients' time without disease compared to the usual approach (chemotherapy and bevacizumab).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Histologically confirmed advanced/metastatic colorectal adenocarcinoma for which metastasectomy is not planned. * No known mismatch repair deficiency (dMMR) or high-frequency microsatellite instability (MSI-H) disease. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. * No prior systemic treatment for metastatic disease. * Patients may have received prior neoadjuvant or adjuvant chemotherapy and/or chemoradiation. The last course of adjuvant therapy must have been completed \> 12 months prior to colorectal cancer recurrence. * Patients may have received prior standard rectal cancer chemoradiation. Previous radiation therapy must have been completed \>= 4 weeks prior to registration. * No continuous daily use of vitamin D supplements \>= 2,000 IU per day for the 12 months prior to registration. Patients may have had continuous daily use of vitamin D supplements \>= 2,000 IU per day if total duration \< 12 months in the 12 months prior to registration. Patients may have had continuous daily use of vitamin D supplements \< 2,000 IU per day for any duration prior to registration. * Patients must have completed any major surgery or open biopsy \>= 4 weeks prior to registration and must have completed any minor surgery or core biopsy \>= 1 week prior to registration. (Note: insertion of a vascular access device is not considered major or minor surgery.) Patients must have recovered from the effects of any surgery (e.g. wound is healed, no active infection, no drains, etc.) prior to registration. * Not pregnant and not nursing. This study involves an agent that has known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =\< 14 days prior to registration is required. * Eastern Cooperative Oncology Group (ECOG) performance status: 0-1. * Absolute neutrophil count \>= 1,500/mm\^3. * Platelet count \>= 100,000/mm\^3. * Hemoglobin \>= 9 g/dL. * Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (Calc.) creatinine clearance (CrCl) \> 30 mL/min. * Calcium =\< 1.0 x ULN. \* Corrected for albumin level if albumin not within institutional limits of normal. * Total bilirubin =\< 1.5 x ULN. \* If Gilbert's disease, use direct bilirubin instead of total bilirubin; direct bilirubin =\< 1.5 x ULN if patient to receive FOLFIRI; direct bilirubin =\< 3.0 x ULN if patient to receive leucovorin, infusional fluorouracil, and oxaliplatin (modified \[m\]FOLFOX6). * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN. \* AST/ALT \< 5 x ULN if clearly attributable to liver metastases. * Urine protein to creatinine (UPC) ratio =\< 1 mg/dL OR urine protein =\< 1+. \* If urine protein is above 1, then 24-hour urine must be ≤ 1 g/24 hours. * No resectable metastatic disease for which potentially curative metastasectomy is planned. * No "currently active" second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy and have been free of disease for \>= 3 years. * No significant history of bleeding events or bleeding diathesis =\< 6 months of registration unless the source of bleeding has been resected. * No history of arterial thrombotic events, including, but not limited to, transient ischemic attack, cerebrovascular accident, unstable angina, angina requiring surgical or medical intervention, or myocardial infarction =\< 6 months of registration. * No history of clinically significant peripheral artery disease =\< 6 months of registration. * No history of uncontrolled congestive heart failure defined as New York Heart Association (NYHA) class III or greater. * No history of gastrointestinal (GI) perforation =\< 12 months of registration except for GI perforation related to a primary colorectal tumor that has since been fully resected. * No history of malabsorption, uncontrolled vomiting or diarrhea, or any other disease significantly affecting GI function that could interfere with the absorption of oral agents. * No history of allergic reaction attributed to compounds of similar chemical or biological composition to the study agents. * No uncontrolled hypertension (defined as blood pressure \[BP\] \> 160/90). * No serious or non-healing wound, ulcer, or bone fracture. * No uncontrolled intercurrent illness, including, but not limited to, psychiatric illness/social situations that, in the opinion of the treating physician, may increase the risks associated with participation or treatment on the study or may interfere with the conduct of the study or interpretation of the study results. * Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following: * On effective anti-retroviral therapy * Undetectable HIV viral load by standard clinical assay =\< 6 months of registration. * No known pre-existing hypercalcemia =\< 6 months of registration. * No known active hyperparathyroid disease or other serious disturbance of calcium metabolism =\< 5 years of registration. * No predisposing colonic or small bowel disorders in which symptoms are uncontrolled as indicated by \> 3 watery or soft stools daily in patients without a colostomy or ileostomy. Patients with a colostomy or ileostomy are allowed per treating physician discretion. * No symptomatic genitourinary stones =\< 12 months of registration. * Patients with treated brain metastases are eligible if follow-up imaging after central nervous system (CNS)-directed therapy shows no evidence of progression \>= 28 days prior to registration. * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS-specific treatment is not required and is unlikely to be required during the first cycle of protocol-specified therapy after registration. * No uncontrolled seizure disorders. * No grade \>=2 peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 regardless of causality. * Patients must be able to swallow oral formulations of the agent. * Concurrent use of supplemental calcium and/or vitamin D is not permitted. Patients must discontinue the supplement(s) at least 7 days prior to registration. * Concurrent use of thiazide diuretics (e.g. hydrochlorothiazide) is not permitted. Patients must discontinue the drug(s) or switch to an alternative anti-hypertensive agent at least 7 days prior to registration. * Chronic concomitant treatment with oral corticosteroids, lithium, phenytoin, quinidine, isoniazid, and/or rifampin are not permitted. Patients must discontinue the agent(s) at least 7 days prior to registration. Short-term use of corticosteroids as antiemetic therapy is acceptable. * Concurrent use of other anti-cancer therapy including chemotherapy, targeted, and/or biological agents is not permitted.

Primary outcome measure(s)

  • Progression-free Survival (PFS) — 4 years
    Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. Progression-free survival (PFS) will be compared between treatment arms using the un-stratified log-rank test at one-sided level of 0.05 and the p-value will be used for decision making. The hazard ratio (HR) for PFS will be estimated using a Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced. Brookmeyer-Crowley methodology will be used to construct the 95% CI for the median PFS for each treatment arm. All randomized patients regardless of any treatment received will be included in the analysis. Patients will be assigned to the treatment group they were randomized to regardless of actual treatment received.

Trial sites (1031)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama
Anchorage Associates in Radiation Medicine Anchorage Alaska
Anchorage Radiation Therapy Center Anchorage Alaska
Alaska Breast Care and Surgery LLC Anchorage Alaska
Alaska Oncology and Hematology LLC Anchorage Alaska
Alaska Women's Cancer Care Anchorage Alaska
Anchorage Oncology Centre Anchorage Alaska
Katmai Oncology Group Anchorage Alaska
Providence Alaska Medical Center Anchorage Alaska
Fairbanks Memorial Hospital Fairbanks Alaska
CTCA at Western Regional Medical Center Goodyear Arizona
Kingman Regional Medical Center Kingman Arizona
Cancer Center at Saint Joseph's Phoenix Arizona
Mercy Hospital Fort Smith Fort Smith Arkansas
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
John L McClellan Memorial Veterans Hospital Little Rock Arkansas
University of Arkansas for Medical Sciences Little Rock Arkansas
Kaiser Permanente-Deer Valley Medical Center Antioch California
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
PCR Oncology Arroyo Grande California
Sutter Auburn Faith Hospital Auburn California
Alta Bates Summit Medical Center-Herrick Campus Berkeley California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
Community Cancer Institute Clovis California
University Oncology Associates Clovis California
City of Hope Comprehensive Cancer Center Duarte California
Epic Care-Dublin Dublin California
Kaiser Permanente Dublin Dublin California
Bay Area Breast Surgeons Inc Emeryville California
Epic Care Partners in Cancer Care Emeryville California
Kaiser Permanente-Fremont Fremont California
Palo Alto Medical Foundation-Fremont Fremont California
Fresno Cancer Center Fresno California
Kaiser Permanente-Fresno Fresno California
Los Angeles County-USC Medical Center Los Angeles California
USC / Norris Comprehensive Cancer Center Los Angeles California
Cedars Sinai Medical Center Los Angeles California
Contra Costa Regional Medical Center Martinez California
Memorial Medical Center Modesto California
Kaiser Permanente-Modesto Modesto California

+ 991 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04094688 on ClinicalTrials.gov ↗ ← All trials in Egypt