Brief Title
Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
Official Title
A Phase II Study of MGI-114 in Patients With Recurrent or Persistent Epithelial Ovarian Cancer
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have
recurrent or persistent ovarian, fallopian tube, or peritoneal cancer.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
irofulven
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
September 1998
Completion Date
April 2004
Eligibility 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gisele A. Sarosy, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00019552
Organization ID
CDR0000066696
Secondary IDs
NCI-98-C-0162
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Gisele A. Sarosy, MD, Study Chair, National Cancer Institute (NCI)
Verification Date
January 2002