Study of Vitamin D in Untreated Metastatic Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT01516216 |
Recruitment Status
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Active, not recruiting
First Posted
: January 24, 2012
Last Update Posted
: February 9, 2018
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Tracking Information | ||||
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First Submitted Date ICMJE | January 13, 2012 | |||
First Posted Date ICMJE | January 24, 2012 | |||
Last Update Posted Date | February 9, 2018 | |||
Study Start Date ICMJE | March 2012 | |||
Estimated Primary Completion Date | March 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression Free Survival [ Time Frame: 2 years ] To compare the progression-free survival (PFS) of participants with previously untreated metastatic colorectal cancer randomized to FOLFOX-bevacizumab plus higher-dose vitamin D versus FOLFOX-bevacizumab plus standard-dose vitamin D
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01516216 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Vitamin D in Untreated Metastatic Colorectal Cancer | |||
Official Title ICMJE | Randomized, Double-Blind, Phase II Trial of Vitamin D Supplementation in Patients With Previously Untreated Metastatic Colorectal Cancer | |||
Brief Summary | The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the receptor in the cancer cells, it may stop cancer cells from growing abnormally and may cause cell death. Vitamin D has been used in other research studies and information from those other research studies suggests that Vitamin D may help in the treatment of colorectal cancer. In this research study, the investigators are comparing standard and higher dose Vitamin D treatment when given in combination with standard treatment for metastatic colorectal cancer. Standard treatment includes the chemotherapy combination of 5-FU, Leucovorin and Oxaliplatin (FOLFOX) with bevacizumab. |
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Detailed Description | Participants will be randomized into one of the study groups-Arm A: Vitamin D (standard dose of 400 IU/day), FOLFOX and Bevacizumab or Arm B: Vitamin D (higher dose of 8000 IU/day for 2 weeks followed by 4000 IU/day), FOLFOX and Bevacizumab. Study Treatment (A cycle of treatment is 14 days): Vitamin D Cycle 1: You will take two capsules of Vitamin D orally, once a day (at the same time), every day. Participants randomized to Arm A will be taking one capsule with 400 IU of Vitamin D and one capsule with placebo (pills with no medicine) so that neither you nor your doctor will know what group you have been assigned to. Participants randomized to Arm B will be taking two capsules of 4000 IU each. Subsequent Cycles: You will take one capsule orally, once a day (at the same time), every day. Participants randomized to Arm A will be taking one capsule with 400 IU of Vitamin D. Participants randomized to Arm B will be taking one capsule with 4000 IU of Vitamin D. FOLFOX and bevacizumab FOLFOX and bevacizumab will be given intravenously (IV, through a vein in your arm) on Day 1 of every cycle for all participants in both Arms A and B. The infusions will take several hours, in addition to your doctor's visit, so you should plan on being in clinic most of the day. Note that the 5-FU is given bolus on day 1 (given as one dose), and is then given as a continuous IV infusion over 2 days. You will need to have a port-a-cath placed. A port-a-cath is a medical device that is placed under the skin. The continuous infusion is delivered by a pump that is inserted into the port-a-cath. The pump will be carried in a pouch that you can hook around your waist. Arrangements will be made for you to have the pump disconnected after 2 days. You may need to return to clinic to have it disconnected. While on study, the following tests and procedures will be performed: Cycle 1, Day 1
Subsequent Cycles, Day 1
Every 4 cycles (approximately every 8 weeks): An assessment of your tumor by CT scan or MRI. Additional blood samples for research: Samples will be drawn (a little more than 1 teaspoon of blood) after Cycle 4, Cycle 8 and then every 8 Cycles thereafter. You will continue to receive treatment as long as your disease does not get worse and you are tolerating the treatment. End of treatment
After the final dose of the study drug: You will be followed for safety reasons for 30 days after the last dose of study drug. If you are experiencing side effects, you may continue to be followed until the side effects resolve or until you start another treatment. If you discontinue study treatment for reasons other than disease progression (for example, side effects), you will be asked to continue to get tumor assessments every 8 - 16 weeks until your disease worsens as demonstrated by a tumor assessment or until you start another therapy to treat your cancer. These assessments may coincide with your routine follow-up, in which case they would not need to be repeated. We would like to keep track of your medical condition for the rest of your life. We would like to do this by reviewing your medical records and/or by calling you on the telephone every 3 months to see how you are doing. Keeping in touch with you and checking on your condition helps us look at the long-term effects of the research study. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Colorectal Cancer | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Estimated Enrollment ICMJE |
120 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Study Completion Date | Not Provided | |||
Estimated Primary Completion Date | March 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01516216 | |||
Other Study ID Numbers ICMJE | 11-436 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Kimmie Ng, MD, Dana-Farber Cancer Institute | |||
Study Sponsor ICMJE | Dana-Farber Cancer Institute | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | |||
Verification Date | February 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |