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

Conditions

• Stage IV Colon Cancer
• Stage IV Rectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• leucovorin calcium — DRUG
  Given IV
• bevacizumab — BIOLOGICAL
  Given IV
• cholecalciferol — DIETARY_SUPPLEMENT
  Given PO
• fluorouracil — DRUG
  Given IV
• oxaliplatin — DRUG
  Given IV
• pharmacological study — OTHER
  Correlative studies

Study Details

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

Key Dates

First listed

Sep 10, 2010

Start date

Aug 31, 2010

Status verified

Jun 2014

Primary completion

Apr 30, 2012

Completion

Jun 30, 2012

Study Design

Enrollment

10 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (FOLXFOX, bevacizumab, cholecalciferol)
  Patients 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

Primary Outcome Measure

Median PFS [ Time Frame: Up to 12 months ]

Locations (1)

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