Spots Global Cancer Trial Database for Safety and Efficacy Study of Glufosfamide in Ovarian Cancer
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Trial Identification
Brief Title: Safety and Efficacy Study of Glufosfamide in Ovarian Cancer
Official Title: An Open-Label Phase 2 Study of the Safety and Efficacy of Glufosfamide in Ovarian Cancer
Study ID: NCT00442598
Conditions
Interventions
Study Description
Brief Summary: Primary Objectives: * To evaluate the effect of glufosfamide on the serum concentrations of CA125 in subjects with ovarian cancer * To evaluate the safety of weekly glufosfamide dosing in subjects with ovarian cancer as compared with every 21-day dosing Secondary objectives: * To evaluate the efficacy of glufosfamide in subjects with ovarian cancer as measured by objective response rate, duration of response, progression-free survival, and overall survival * To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard during and after treatment Exploratory objective: * To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins
Detailed Description: Open-label, multicenter, Phase 2 dose escalation study. Subjects will be randomized to receive either once every three weeks dosing regimen or the weekly dosing regimen. Randomization will utilize a 2:1 ratio with two-thirds of the subjects randomized to the weekly dosing regimen. In the weekly dosing schedule, treatment with glufosfamide 2,500 mg/m2 will be initiated only after the 1,660 mg/m2 treatment cohort has been enrolled and there is evidence that the dose of 1,660 mg/m2 has been well tolerated (See below Section on Pharmacokinetic/Statistical Analyses).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Premiere Oncology of Arizona, Scottsdale, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
California Cancer Center, Greenbrae, California, United States
UCI Chao Family Comprehensive Cancer Center, Orange, California, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Louisville Oncology Clinical Research Program, Louisville, Kentucky, United States
New Mexico Cancer Care Alliance, Albuquerque, New Mexico, United States
Gabrail Cancer Center, Canton, Ohio, United States
Gynecologic Oncology Research & Development, LLC, Greenville, South Carolina, United States
Harrington Cancer Center, Amarillo, Texas, United States
Contact Details
Name: David Alberts, MD
Affiliation: University of Arizona
Role: PRINCIPAL_INVESTIGATOR
Name: Michael Gordon, MD
Affiliation: Premiere Oncology of Arizona
Role: PRINCIPAL_INVESTIGATOR
Name: Daniela Matei, MD
Affiliation: Indiana University School of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Peter D Eisenberg, MD
Affiliation: California Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Larry Puls, MD
Affiliation: Gynecologic Oncology Research & Development, LLC
Role: PRINCIPAL_INVESTIGATOR
Name: Krishnansu Tewari, MD
Affiliation: UCI Chao Family Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Nashat Gabrail, MD
Affiliation: Gabrail Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Jeffrey Goldberg, MD
Affiliation: Louisville Oncology Clinical Research Program
Role: PRINCIPAL_INVESTIGATOR
Name: Claire Verschraegen, M.D.
Affiliation: New Mexico Cancer Care Alliance
Role: PRINCIPAL_INVESTIGATOR
Name: William Robinson, MD
Affiliation: Harrington Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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