Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
|First Received Date ICMJE||July 11, 2001|
|Last Updated Date||June 19, 2013|
|Start Date ICMJE||September 1998|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00019552 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer|
|Official Title ICMJE||A Phase II Study of MGI-114 in Patients With Recurrent or Persistent Epithelial Ovarian Cancer|
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.
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 Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Drug: irofulven|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||April 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00019552|
|Other Study ID Numbers ICMJE||CDR0000066696, NCI-98-C-0162, MB-403, NCI-T98-0030|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||January 2002|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP