FAU in Treating Patients With Advanced Solid Tumors or Lymphoma
A Phase I Study of Intravenously Administered FAU (1-(2'-Deoxy-2'-Fluoro-B-D-arabinofuranosyl) Uracil, NSC#678515) in Patients With Advanced Solid Tumors
7 other identifiers
interventional
12
1 country
1
Brief Summary
Drugs used in chemotherapy, such as FAU, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. This phase I trial is studying the side effects and best dose of FAU in treating patients with advanced solid tumors or lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2008
CompletedFirst Posted
Study publicly available on registry
October 9, 2008
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedJanuary 7, 2014
January 1, 2014
4.4 years
October 8, 2008
January 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose, defined as the dose at which no more than 1/6 patients develops dose-limiting toxicity, graded by NCI CTCAE version 4.0
Up to 28 days
Secondary Outcomes (2)
Clinical response to FAU, evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee
Up to 30 days
Pharmacokinetics of FAU, including Cmax, Tmax, AUC 0-last, AUC 0-infinity, CL, t1/2, and Vss
Days 1 and 22 of course 1 at pre-treatment; at the end of infusion; and following the end of infusion at 15 and 30 minutes and 1, 2, 4, 8, and 24 hours
Study Arms (1)
I
EXPERIMENTALPatients will receive a 1-hour infusion of FAU on days 1-5.
Interventions
Correlative studies
Eligibility Criteria
You may qualify if:
- Measurable disease by CT scan and/or MRI
- Archival tumor tissue sample available for correlative pharmacodynamic and pharmacogenomic studies
- Accessible tumor tissue available (for patients enrolled in the expanded maximum tolerated dose \[MTD\] cohort)
- No known active brain metastases but previously treated brain metastases allowed
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- AST and ALT =\< 2.5 times upper limit of normal (ULN) (=\< 5 times ULN if liver metastases are present)
- Alkaline phosphatase =\< 2.0 times ULN (=\< 5 times ULN if bone or liver metastases are present)
- Bilirubin normal
- Creatinine normal or creatinine clearance \>= 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to undergo tumor biopsies for correlative pharmacodynamic studies (for patients enrolled in the expanded MTD cohort)
- Able to lie still for PET scan
- Weight =\< 300 lbs
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wayne State University
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia LoRusso
Wayne State University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2008
First Posted
October 9, 2008
Study Start
July 1, 2009
Primary Completion
December 1, 2013
Last Updated
January 7, 2014
Record last verified: 2014-01