Dose Escalation Trial of 2-Deoxy-D-Glucose (2DG) in Subjects With Advanced Solid Tumors
Phase I Dose Escalation Trial of 2-Deoxy-D-Glucose (2DG) Alone and in Combination With Docetaxel in Subjects With Advanced Solid Malignancies
1 other identifier
interventional
50
1 country
3
Brief Summary
The objectives of this study are to evaluate the safety, tolerability, pharmacokinetics, and biologic effect (FDG PET, preliminary efficacy) of daily oral doses of 2DG with and without weekly docetaxel in subjects with advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 lung-cancer
Started Feb 2004
Typical duration for phase_1 lung-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 12, 2004
CompletedFirst Posted
Study publicly available on registry
November 15, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedApril 29, 2009
April 1, 2009
4.4 years
November 12, 2004
April 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Significant Toxicity
Disease Progression
Secondary Outcomes (2)
Response Rate
Death
Interventions
Eligibility Criteria
You may qualify if:
- Males and females, at least 18 years of age
- Histologically confirmed, locally advanced or metastatic solid malignancy
- Previously treated with at least one chemotherapy regimen for advanced or metastatic disease OR no curative standard treatment is available
- Recovered from reversible toxicities of prior therapy
- Life expectancy of at least 3 months
- ECOG performance status of 0, 1, or 2
- Measurable or nonmeasurable disease by RECIST criteria
- Ability to understand the purposes and risks of the study and having signed a written informed consent form
- All women of childbearing potential and all men must agree to use effective means of contraception from entry into the study through 3 months after the last dose
You may not qualify if:
- Previous or current CNS metastases (screening CT or MRI is not required in asymptomatic subjects)
- Active clinically significant infection requiring antibiotics
- Known glucose-6-phosphate dehydrogenase deficiency or history of anemia of unknown etiology
- History of clinically significant unexplained episodes of hypotension, fainting, dizziness, or lightheadedness
- History or symptoms of cardiovascular disease, particularly coronary artery disease, arrhythmias, or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure
- History of transient ischemic attack, stroke, or seizure disorder or any other CNS disease considered to be significant by the investigator
- Known autonomic dysfunction or chronic orthostatic hypotension
- Evidence of hypoglycemia, clinically significant renal disease, clinically significant liver disease (other than liver metastases), diabetes mellitus, gastrointestinal disorder (that could affect absorption or elimination of orally-administered medications), or obstructive uropathy with significant post-void residual during the past 5 years
- Known HIV infection
- Other primary malignancies (other than treated basal cell carcinoma of the skin or treated in situ cervical cancer) within the past 5 years
- Major surgery within 4 weeks of the start of study treatment, without complete recovery
- Antitumor therapy within 21 days of the start of study treatment
- Disease progression/relapse on docetaxel therapy within the past 12 months
- A history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- Known sensitivity to methylparaben or propylparaben
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Institute for Drug Development Cancer Therapy & Research Center
San Antonio, Texas, 78229, United States
Related Publications (1)
Raez LE, Papadopoulos K, Ricart AD, Chiorean EG, Dipaola RS, Stein MN, Rocha Lima CM, Schlesselman JJ, Tolba K, Langmuir VK, Kroll S, Jung DT, Kurtoglu M, Rosenblatt J, Lampidis TJ. A phase I dose-escalation trial of 2-deoxy-D-glucose alone or combined with docetaxel in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2013 Feb;71(2):523-30. doi: 10.1007/s00280-012-2045-1. Epub 2012 Dec 11.
PMID: 23228990DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis Raez, MD
University of Miami Sylvester Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 12, 2004
First Posted
November 15, 2004
Study Start
February 1, 2004
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
April 29, 2009
Record last verified: 2009-04