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19F-MRS (Magnetic Resonance Spectroscopy) Studies of in-vivo 5-Fluorouracil Pharmacokinetics with and without Bevacizumab in Patients with Liver Metastases from Adenocarcinoma of the Colon

Conditions

Colon | Colon Cancer

Trial Phase

Phase II

Trial Purpose and Description

Trial Purpose

This is a clinical research study that is designed to test if the administration of another medicine, called bevacizumab, an antibody that blocks blood vessels growth (angiogenesis) will increase the amount of your prescribed 5-FU that gets into the cancer cells in the liver. The objective is to perform 19F-MRS on patients with colorectal cancer liver metastases in order to determine the concentration of 5FU in liver metastases and AUC for the 48 hour infusion when given with and without bevacizumab. To correlate intratumoral pharmakinetic parameters with plasma 5FU levels and plasma 5FU AUC, and correlation of intratumoral 5FU with time to progression on current regimen Patients will be treated twice only on this study, once using a conventional 5FU based chemotherapy for colorectal cancer and a second time using bevacizumab followed by the same chemotherapy.


Participation Guidelines

Age:
18 Years and older
Gender:
Both

Eligibility Criteria

Histologic diagnosis of colorectal adenocarcinoma

  1. Measurable liver metastases from CRC by conventional CT or MRI imaging scanning.
  2. No prior radiation to the liver
  3. Prior therapy is allowed, including prior therapy with 5FU. Bevacizumab should not have been given for 8 weeks prior to study, though 6 weeks may be acceptable if clinically indicated and approved by Pl.
  4. Only patients for whom bevacizumab is clinically indicated are to enrolled
  5. Adequate organ function with:
    Absolute Neutrophil Count (ANC)1000/ul platelet count 50,000/ul
    bilirubin 1.5 mg/dl
    SGOT, alk phos5x upper limit of normal
    Serum creatinine 1.5 x upper limit of normal
  6. ECOG performance status 0 or 1.
  7. Anticipated life expectancy of at least 3 months.
  8. For women of childbearing potential: Not pregnant or lactating.
  9. Women of childbearing potential and sexually active males must use an accepted and effective method of contraception.
  10. No MRI contraindications.
  11. Signed, written informed consent obtained prior to study participation
Sponsor:
Yale Cancer Center
Dates:
10/12/2012
Last Updated:
Study HIC#:
1110009169