Study on Vitamin D3 with Chemotherapy and Bevacizumab for Advanced or Metastatic Colorectal Cancer
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT04094688
This clinical trial is exploring whether adding high-dose vitamin D3 to standard chemotherapy and bevacizumab can better control colorectal cancer that has spread. The study aims to see if this combination can help shrink or stabilize the cancer more effectively than the usual treatment.
Patient Parameters
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Program Overview
This study is investigating if high-dose vitamin D3, when combined with standard chemotherapy drugs and the immunotherapy drug bevacizumab, can improve treatment outcomes for patients with advanced or metastatic colorectal cancer. Vitamin D3 is known for helping the body use calcium and phosphorus to strengthen bones and teeth. The chemotherapy drugs work by stopping cancer cells from growing and spreading, while bevacizumab helps the immune system attack cancer cells. Researchers want to find out if adding high-dose vitamin D3 can extend the time patients remain free of disease compared to the standard treatment approach.
Description
The study has two main groups of patients. In one group, patients receive high-dose vitamin D3 along with standard chemotherapy and bevacizumab. In the other group, patients receive a standard dose of vitamin D3 with the same chemotherapy and bevacizumab. The study will compare how long patients in each group live without the cancer getting worse, how well the cancer responds to treatment, and overall survival rates. Researchers will also look at the side effects of high-dose versus standard-dose vitamin D3 and how lifestyle factors like diet and physical activity might affect treatment outcomes. Patients will be followed for up to five years to monitor their health and the effectiveness of the treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with advanced or metastatic colorectal cancer that cannot be surgically removed.
- No known genetic markers that affect treatment response.
- Cancer must be measurable by standard criteria.
- No prior treatment for metastatic cancer, but previous treatment for earlier stages is allowed if completed over a year ago.
- No continuous use of high-dose vitamin D supplements in the past year.
- Must have recovered from any recent surgeries.
- Not pregnant or nursing, with a negative pregnancy test required for women of childbearing potential.
- Good overall health with specific blood counts and organ function within normal limits.
- No other active cancers or serious health conditions that could interfere with the study.
- HIV-positive patients are eligible if on effective treatment with an undetectable viral load.
- No history of high calcium levels or other serious calcium metabolism disorders.
- Able to swallow oral medications and willing to stop certain supplements and medications before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
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