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Safety and Efficacy Study of Glufosfamide in Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00442598
Recruitment Status : Terminated
First Posted : March 2, 2007
Results First Posted : March 10, 2015
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
Eleison Pharmaceuticals LLC.

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Glufosfamide Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 2 Study of the Safety and Efficacy of Glufosfamide in Ovarian Cancer
Study Start Date : January 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Glufosfamide q21 days
1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Drug: Glufosfamide
Experimental: Glufosfamide q7 days low
1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Drug: Glufosfamide
Experimental: Glufosfamide q7 days high
1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Drug: Glufosfamide



Primary Outcome Measures :
  1. CA 125 Response Rate [ Time Frame: Duration of study, up to 18 weeks. ]
    Reduction in blood levels of CA 125 of >50% from baseline, confirmed at the next study cycle.


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Duration of study, up to 18 weeks. ]
    Objective response rate measured by RECIST v1.0

  2. Progression-free Survival [ Time Frame: Median measured in months ]
    Time from initiation of study drug to disease progression or death on study

  3. Overall Survival [ Time Frame: Median measured in months, until death or censorship at analysis. ]
    Time from initiation of study drug to death.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
  • Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or carcinoma of the fallopian tube
  • Prior treatment with at least one platinum-based chemotherapy
  • Evidence of resistance to most recent platinum-containing regimen (relapsed during or within 6 months after completing chemotherapy)
  • Evidence of CA 125 progression after most recent chemotherapy defined as either:

    • CA 125 at least 40 U/mL for patients with elevated CA 125 that decreased to <20 U/mL on therapy; or
    • CA 125 at least 40 U/mL and at least a 50% increase over the nadir value for patients with elevated CA 125 that did not decrease to <20 U/mL on therapy.

CA 125 must meet criteria on two occasions not less than one week apart if the CA 125 has increased by at least 100% (i.e., doubled). There must be 3 consecutive increasing measurements over a period of at least two weeks if the CA 125 has increased by at least 50% but less than 100%.

  • Elevated serum CA125 (≥40 U/mL) within 2 weeks prior to starting treatment
  • At least one target or nontarget lesion by RECIST
  • A minimum of 21 days between prior chemotherapy, radiation therapy, immunotherapy, or other anti-tumor therapy and study entry
  • Recovered from reversible toxicities of prior therapy
  • ECOG score of 0 or 1
  • ANC ≥ 1,500/µL, platelets ≥ 100,000/µL, hemoglobin ≥9 g/dL
  • Total bilirubin ≤ 1.5-fold ULN, AST/ALT ≤ 2.5-fold ULN (≤ 5-fold ULN if liver metastases)
  • Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault formula)
  • All women of childbearing potential must have a negative serum pregnancy test and must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose

Exclusion Criteria:

  • Concomitant or planned hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for ovarian cancer other than protocol therapy
  • Symptomatic brain metastases
  • Active clinically significant infection requiring antibiotics
  • Known HIV positive or active hepatitis B or C
  • Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, congestive heart failure or stroke
  • Other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
  • Major surgery within 3 weeks of the start of study treatment, without complete recovery
  • Females who are pregnant or breast-feeding
  • Participation in an investigational drug or device study within 28 days of the first day of dosing on this study
  • Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
  • Unwillingness or inability to comply with the study protocol for any other reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442598


Locations
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United States, Arizona
Premiere Oncology of Arizona
Scottsdale, Arizona, United States, 85260
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
California Cancer Center
Greenbrae, California, United States, 94904
UCI Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Louisville Oncology Clinical Research Program
Louisville, Kentucky, United States, 40202
United States, New Mexico
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States, 87106
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, South Carolina
Gynecologic Oncology Research & Development, LLC
Greenville, South Carolina, United States, 29601
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
Sponsors and Collaborators
Eleison Pharmaceuticals LLC.
Investigators
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Principal Investigator: David Alberts, MD University of Arizona
Principal Investigator: Michael Gordon, MD Premiere Oncology of Arizona
Principal Investigator: Daniela Matei, MD Indiana University School of Medicine
Principal Investigator: Peter D Eisenberg, MD California Cancer Center
Principal Investigator: Larry Puls, MD Gynecologic Oncology Research & Development, LLC
Principal Investigator: Krishnansu Tewari, MD UCI Chao Family Comprehensive Cancer Center
Principal Investigator: Nashat Gabrail, MD Gabrail Cancer Center
Principal Investigator: Jeffrey Goldberg, MD Louisville Oncology Clinical Research Program
Principal Investigator: Claire Verschraegen, M.D. New Mexico Cancer Care Alliance
Principal Investigator: William Robinson, MD Harrington Cancer Center
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Responsible Party: Eleison Pharmaceuticals LLC.
ClinicalTrials.gov Identifier: NCT00442598    
Other Study ID Numbers: TH-CR-303
First Posted: March 2, 2007    Key Record Dates
Results First Posted: March 10, 2015
Last Update Posted: March 10, 2015
Last Verified: March 2015
Keywords provided by Eleison Pharmaceuticals LLC.:
Ovarian
Cancer
CA-125
Third-line
Glufosfamide
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type