Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00019552
First received: July 11, 2001
Last updated: June 19, 2013
Last verified: January 2002
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: irofulven
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of MGI-114 in Patients With Recurrent or Persistent Epithelial Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1998
Study Completion Date: April 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019552

Locations
United States, Maryland
Medicine Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Study Chair: Gisele A. Sarosy, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00019552     History of Changes
Other Study ID Numbers: CDR0000066696, NCI-98-C-0162, MB-403, NCI-T98-0030
Study First Received: July 11, 2001
Last Updated: June 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Irofulven
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014