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An Open-Label Phase 2 Study of the Safety and Efficacy of Glufosfamide in Ovarian Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

An Open-Label Phase 2 Study of the Safety and Efficacy of Glufosfamide in Ovarian Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CA 125 response rate

Principal Investigator

David Alberts, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona

Authority:

United States: Food and Drug Administration

Study ID:

TH-CR-303

NCT ID:

NCT00442598

Start Date:

January 2007

Completion Date:

April 2008

Related Keywords:

  • Ovarian Cancer
  • Ovarian
  • Cancer
  • CA-125
  • Cisplatin
  • Carboplatin
  • Third-line
  • Glufosfamide
  • Platinum Resistance
  • Women with ovarian cancer resistant to cisplatin- or carboplatin-based therapy
  • Ovarian Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
California Cancer CenterFresno, California  93720
Harrington Cancer CenterAmarillo, Texas  79106
Gabrail Cancer CenterCanton, Ohio  44718
New Mexico Cancer Care AllianceAlbuquerque, New Mexico  87106
Premiere Oncology of ArizonaScottsdale, Arizona  85260
Gynecologic Oncology Research & Development, LLCGreenville, South Carolina  29601
UCI Chao Family Comprehensive Cancer CenterOrange, California  92868
Louisville Oncology Clinical Research ProgramLouisville, Kentucky  40202