Using Positron Emission Tomography to Evaluate the Effects of Bevacizumab on Intra-tumoral Pharmacokinetics of 5-fluorouracil in Metastatic Colorectal Cancer
Colorectal Cancer, Neoplasm Metastasis
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Positron emission tomography, PET, bevacizumab, 5fluorouracil, Metastatic colorectal cancer
Eligibility Criteria
Inclusion Criteria: Metastatic colorectal cancer subjects Subjects must have at least one non-radiated FDG-glucose avid (as demonstrated by an FDG-glucose PET scan) liver metastasis of at least 2 cm in size. Subjects must have never received chemotherapy for metastatic disease; subjects may have received adjuvant chemotherapy for presumed early stage disease if it was completed at least 12 months prior to study entry date All subjects must have already consented to an on-label use of a BV and fluorouracil containing first-line chemotherapy regimen (either with irinotecan or oxaliplatin) and must be a candidate for such a therapy as defined by the enrolling investigator and the community standard of care. As such a chemotherapy regimen requires an infusion port, this port should be placed at least two weeks prior to the subject's first dose of bevacizumab. Chronological age ≥ 18 years. ECOG performance status ≤ 2. Life expectancy ≥ 12 weeks. Women must not be pregnant or lactating. Both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study. Subjects with concurrent malignancy of any site are eligible if the disease is under adequate control. All subjects must sign informed consent. Exclusion Criteria: Subjects in "visceral crises", meaning a delay in achieving tumor response by 2 weeks may result in organ failure, are ineligible for this study. Subjects who are planned to undergo treatment with fluorouracil and bevacizumab alone (without irinotecan or oxaliplatin) are ineligible for this trial.
Sites / Locations
- Dana-Farber Cancer Institute
- Massachusetts General Hospital