Study Comparing Optimized 5-FU Dosing and Standard Dosing in Metastatic Colorectal Cancer Patients Treated With mFOLFOX6 (PROFUSE)
This study has been terminated.
(Study terminated due to slow enrollment.)
Sponsor:
Myriad Genetic Laboratories, Inc.
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT01468623
First received: November 1, 2011
Last updated: January 29, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to compare OnDose® based pharmacokinetic administration of 5-FU versus standard Body Surface Area (BSA) based administration of 5-FU in patients with metastatic colorectal cancer treated with mFOLFOX6, with or without bevacizumab, to determine if the use of OnDose® achieves an improvement in the Overall Response Rate (ORR) relative to BSA dosing response.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer, Metastatic |
Other: Pharmacokinetic 5-FU dose adjustment using OnDose® assay Other: Standard of care |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Open-label Trial Comparing OnDose® AUC Optimized 5-FU Based Administration Versus Standard Body Surface Area (BSA) Dosing in Metastatic Colorectal Cancer Patients (mCRC) Treated With mFOLFOX6 |
Resource links provided by NLM:
Further study details as provided by Myriad Genetic Laboratories, Inc.:
Primary Outcome Measures:
- Overall response rate (ORR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival (PFS) [ Time Frame: 30 months ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: OnDose®
Patients will receive FOLFOX6 with or without bevacizumab (Avastin). Patients' 5-FU dose will be optimized by measuring the Area Under the Curve (AUC) of 5-FU by the commercially available OnDose® assay and their dose for subsequent cycles adjusted following a pre-established dose adjustment algorithm.
|
Other: Pharmacokinetic 5-FU dose adjustment using OnDose® assay
OnDose is a commercially available assay to measure concentration of 5-FU exposure.
Other Name: OnDose®
|
|
Active Comparator: Body Surface Area (BSA)
Patients will receive FOLFOX6 with or without bevacizumab (Avastin). Patients will receive 5-FU based on traditional BSA calculation and their dose adjusted based on standard clinical practice. OnDose® AUC measurements will be performed for this arm but will not be used for dose adjustment.
|
Other: Standard of care
Patients' dose of 5-FU will be based on Body Surface Area (BSA).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Selection Criteria:
- Patients with histologically confirmed metastatic colorectal cancer
- No prior chemotherapy for the treatment of metastatic colorectal cancer
- At least one measurable lesion by CT or MRI of ≥ 20 mm (if conventional CT scan) or ≥ 10 mm (if spiral CT scan)
- ECOG Performance Status (ECOG-PS) status ≤ 2
- At least 18 years of age
- Life expectancy > 6 months
- Must be able and willing to give written informed consent
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods (abstinence, condom).
- ANC count greater than or equal to 1,500/ mm³
- Platelets greater than or equal to 100,000/ mm³
- Serum creatinine less than or equal to 2x upper limit of normal (normal range (male): 97-137 mL/min; (female): 88-128 mL/min)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3x the upper limit of normal (≤ 5.0 x ULN is acceptable if liver has tumor involvement) (ALT normal range: < 41 iu/L (male), < 31 iu/L (female); AST normal range: < 37 iu/L (male), < 31 iu/L (female)).
- Prothrombin Time (PT), activated partial thromboplastin time (aPTT) and INR ≤ 1.5 x ULN (INR normal range: 0.8-1.2) or in the therapeutic range if on anticoagulation.
- Hemoglobin greater than or equal to 9 gm/dl (may be corrected by transfusion prior to 5-FU treatment with investigator approval).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468623
Show 58 Study Locations
Show 58 Study LocationsSponsors and Collaborators
Myriad Genetic Laboratories, Inc.
Investigators
| Study Director: | Abebe Haregewoin, MD, PhD | Myriad Genetic Laboratories, Inc. |
More Information
No publications provided
| Responsible Party: | Myriad Genetic Laboratories, Inc. |
| ClinicalTrials.gov Identifier: | NCT01468623 History of Changes |
| Other Study ID Numbers: | PROFUSE-2011 |
| Study First Received: | November 1, 2011 |
| Last Updated: | January 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Myriad Genetic Laboratories, Inc.:
|
Colorectal cancer, metastatic FOLFOX6 5-FU First line bevacizumab |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Bevacizumab |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013