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Stage IV Colon CancerPhase 2NCT01198548

High-Dose Cholecalciferol in Treating Patients Receiving Combination Chemotherapy and Bevacizumab as First-Line Therapy For Metastatic Colorectal Cancer

A Phase 2 study testing leucovorin calcium, bevacizumab and cholecalciferol in people with Stage IV Colon Cancer and Stage IV Rectal Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 cancer. Cholecalciferol during treatment may delay the development of colorectal cancer. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Stage IV Colon Cancer, Stage IV Rectal Cancer
What is being tested?
leucovorin calcium, bevacizumab and cholecalciferol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Aug 2010to Jun 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: A Phase II Clinical Trial of High Dose Vitamin D3 Supplementation in Combination With FOLFOX + Bevacizumab in the 1st Line Treatment of Metastatic Colorectal Cancer

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 cancer. Cholecalciferol during treatment may delay the development of colorectal cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving cholecalciferol together with combination chemotherapy and monoclonal antibody therapy may be an effective treatment for colorectal cancer

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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 (leucovorin calcium, fluorouracil, and oxaliplatin) + bevacizumab + high dose vitamin D3 supplementation (cholecalciferol).

II. To estimate the median progression-free survival (PFS) of metastatic colorectal cancer patients receiving first-line FOLFOX + bevacizumab + high dose vitamin D3 supplementation.

SECONDARY OBJECTIVES:

  1. To estimate the response rate (RR) and the median overall survival (OS) of metastatic colorectal cancer patients receiving first-line FOLFOX + bevacizumab + high dose vitamin D3 supplementation.

II. To describe the safety of this combination by capturing all treatment-related toxicity as per National Cancer Institute-Common Terminology Criteria (NCI-CTC) version 4 guidelines.

OUTLINE:

Patients receive high-dose cholecalciferol orally (PO) once daily. Patients also receive bevacizumab intravenously (IV) over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

NOTE: *Treatment with oxaliplatin is discontinued after course 8.

After completion of study treatment, patients are followed up at day 30 and then 3 months thereafter.

Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • leucovorin calciumDrug

    Also called CF, CFR, LV

    Given IV

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

  • cholecalciferolDietary supplement

    Also called Calciol, Vitamin D3

    Given PO

  • fluorouracilDrug

    Also called 5-fluorouracil, 5-Fluracil, 5-FU

    Given IV

  • oxaliplatinDrug

    Also called 1-OHP, Dacotin, Dacplat, Eloxatin

    Given IV

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT01198548
Study groupRoleWhat they receive
Treatment (FOLXFOX, bevacizumab, cholecalciferol)ExperimentalPatients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8
Receives: Drug: leucovorin calcium; Biological: bevacizumab; Dietary Supplement: cholecalciferol; Drug: fluorouracil; Drug: oxaliplatin; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median PFS

    The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method. The corresponding 95% confidence intervals for the estimated probability will be computed using the method proposed in Clopper and Pearson.

    Measured: Up to 12 months

  2. Rate of Sufficient Cholecalciferol

    Measured: By week 16

Secondary outcomes (4)

  1. RR of Patients Receiving Study Treatment

    Measured: Up to 3 years

  2. Toxicity Rates as Assessed by NCI CTCAE Version 4

    Measured: Up to 30 days post-treatment

  3. OS of Patients Receiving Study Treatment

    The estimated distribution of OS will be obtained using the product-limit based Kaplan-Meier method.

    Measured: Up to 3 years

  4. PFS of Patients Receiving Study Treatment

    The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method.

    3 Year Survival Rate

    Measured: Defined as the time from the start of the study treatment until the date of progression or death from any cause, whichever comes first, assessed up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionApr 2012
  4. Study completionJun 2012

Why it stopped: Lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01198548
Sponsor's protocol ID
I 176910
Other IDs
NCI-2010-01783
Status last verified
Jun 2014
First submitted
8 Sep 2010
Last updated
21 Jul 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing leucovorin calcium, bevacizumab and cholecalciferol in people with Stage IV Colon Cancer and Stage IV Rectal Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median PFS (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01198548.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2014.

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