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A Phase II Study of MGI-114 in Patients With Recurrent or Persistent Epithelial Ovarian Cancer

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Study of MGI-114 in Patients With Recurrent or Persistent Epithelial Ovarian Cancer

OBJECTIVES: I. Determine the clinical activity of irofulven in patients with recurrent or
persistent ovarian epithelial cancer. II. Characterize the pharmacokinetic profile of this
drug in these patients. III. Determine the pharmacodynamic relationship between plasma
concentrations and clinical activity or toxicity of this drug in these patients.

OUTLINE: Patients are stratified according to the number of prior treatment regimens (1-2 vs
3 or more). Patients receive irofulven IV over 5 minutes on days 1-5. Courses repeat every 4
weeks in the absence of disease progression or unacceptable toxicity. Patients are followed
every 4 weeks until death.

PROJECTED ACCRUAL: A maximum of 74 patients will be accrued for this study within 3 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent ovarian
epithelial cancer, primary fallopian tube cancer, or primary peritoneal cancer that failed
prior standard chemotherapy Measurable disease No history of brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Greater than 2 months Hematopoietic: Granulocyte count at least 1,500/mm3 Hemoglobin at
least 9.0 g/dL (transfusion allowed) Platelet count at least 100,000/mm3 Hepatic:
Bilirubin normal ALT and AST no greater than 2.5 times normal PT or PTT no greater than
1.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine
clearance at least 50 mL/min Urinalysis normal BUN normal Electrolytes normal
Cardiovascular: No unstable or newly diagnosed angina pectoris within the past 6 months No
myocardial infarction within the past 6 months No New York Heart Association class II-IV
congestive heart failure Pulmonary: No chronic obstructive lung disease requiring oxygen
supplementation therapy or medication Other: No medical or surgical complications
requiring intervention, such as: Impending bowel obstruction Active infection No other
life-threatening illness No non-skin malignancy or melanoma within the past 4.5 years
except curatively treated other malignancy with low risk of recurrence or surgically cured
stage I endometrial cancer No uncontrolled seizures Not pregnant or nursing HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Recovered from prior biologic therapy No prior
bone marrow transplantation Chemotherapy: See Disease Characteristics At least 4 weeks
since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy:
Recovered from prior endocrine therapy Radiotherapy: Recovered from prior radiotherapy No
prior external beam radiotherapy Surgery: Recovered from prior surgery Other: At least 1
week since prior antibiotics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Gisele A. Sarosy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

September 1998

Completion Date:

April 2004

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Medicine Branch Bethesda, Maryland  20892