Safety and Efficacy Study of Glufosfamide in Ovarian Cancer

NCT00442598 | Terminated Phase 2 Results

• 1 other identifier: TH-CR-303
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 10

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

Conditions

Ovarian Cancer

Keywords

Ovarian; Cancer; CA-125; Third-line; Glufosfamide

Outcome Measures

Primary Outcomes (1)

• CA 125 Response Rate

  Reduction in blood levels of CA 125 of \>50% from baseline, confirmed at the next study cycle.

  Duration of study, up to 18 weeks.

Secondary Outcomes (3)

• Objective Response Rate

  Duration of study, up to 18 weeks.

• Progression-free Survival

  Median measured in months

• Overall Survival

  Median measured in months, until death or censorship at analysis.

Study Arms (3)

Glufosfamide q21 days

EXPERIMENTAL

1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle

Drug: Glufosfamide

Glufosfamide q7 days low

EXPERIMENTAL

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

Glufosfamide q7 days high

EXPERIMENTAL

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

Interventions

Glufosfamide DRUG

Glufosfamide q21 days; Glufosfamide q7 days high; Glufosfamide q7 days low

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eleison Pharmaceuticals LLC.: lead

Study Sites (10)

Premiere Oncology of Arizona

Scottsdale, Arizona, 85260, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

California Cancer Center

Greenbrae, California, 94904, United States

Location

UCI Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Louisville Oncology Clinical Research Program

Louisville, Kentucky, 40202, United States

Location

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87106, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Gynecologic Oncology Research & Development, LLC

Greenville, South Carolina, 29601, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Interventions

beta-D-glucosylisophosphoramide mustard

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: VP Clinical Development
• Organization: Eleison Pharmaceuticals

matthew.parris@eleison-pharma.com

6097211227

Study Officials

• 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 Research Alliance

  PRINCIPAL INVESTIGATOR

• William Robinson, MD

  Harrington Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 2, 2007
• Study Start: January 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: March 10, 2015
• Results First Posted: March 10, 2015

Record last verified: 2015-03

Locations

US (10)