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Irofulven in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cancer
This study is ongoing, but not recruiting participants.
First Received: January 27, 2003   Last Updated: June 10, 2009   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00053365
  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 epithelial cancer or primary peritoneal cancer.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: irofulven
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Evaluation Of Irofulven (IND #55804, NSC #683863) In The Treatment Of Recurrent Or Persistent Platinium-Sensitive Ovarian Or Primary Peritoneal Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Antitumor activity [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2003
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of irofulven in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer.
  • Determine the toxicity of this drug in these patients.

OUTLINE: Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.

Patients are followed at approximately 30 days, every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within at least 6 months.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial or primary peritoneal carcinoma

    • Recurrent or persistent disease
  • At least 1 unidimensionally measurable target lesion* defined as:

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan NOTE: *Tumors within a previously irradiated field are not considered target lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Must have received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for primary disease

    • Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
    • Patients who have not received prior paclitaxel may receive a second regimen containing paclitaxel
  • Ineligible for a higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population)
  • Platinum-sensitive disease

    • Platinum-free interval** of more than 6 months, but less than 12 months duration, with no clinical evidence of progressive disease after response to platinum NOTE: **Any nonplatinum maintenance or consolidation therapy is not included in the calculation of platinum-free interval

PATIENT CHARACTERISTICS:

Age

  • 18 to 85

Performance status

  • GOG 0-2 for patients who received 1 prior therapy regimen
  • GOG 0-1 for patients who received 2 prior therapy regimens

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal

  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular

  • No prior congestive heart failure requiring medication
  • No uncontrolled hypertension within the past 6 months

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
  • No history of retinopathy and/or macular degeneration
  • No neuropathy (sensory and motor) greater than grade 1
  • No active infection requiring antibiotics
  • No other illness or condition that would preclude study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior bone marrow or stem cell transplantation
  • At least 3 weeks since prior biologic therapy or immunotherapy for malignant tumor
  • One prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) allowed

Chemotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy and recovered
  • No prior irofulven
  • No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens

Endocrine therapy

  • At least 1 week since prior hormonal therapy for malignant tumor
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 25% of marrow-bearing areas

Surgery

  • Recovered from recent prior surgery

Other

  • At least 3 weeks since any other prior therapy for malignant tumor
  • No prior anticancer treatment that would preclude study therapy
  • One prior noncytotoxic cytostatic regimen for recurrent or persistent disease allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053365

  Hide Study Locations
Locations
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Colorado
Colorado Gynecologic Oncology Group, PC
Aurora, Colorado, United States, 80010
United States, Connecticut
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
United States, District of Columbia
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Central Georgia Gynecologic Oncology
Macon, Georgia, United States, 31201
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
United States, Illinois
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Louisiana
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Woman's Hospital
Baton Rouge, Louisiana, United States, 70815
United States, Maryland
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, United States, 21204
Union Hospital Cancer Program at Union Hospital
Elkton MD, Maryland, United States, 21921
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
United States, Massachusetts
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
United States, Oklahoma
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States, 74104
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
United States, Tennessee
East Tennessee State University Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, United States, 37604
United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Russell J. Schilder, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000269484, GOG-0146O
Study First Received: January 27, 2003
Last Updated: June 10, 2009
ClinicalTrials.gov Identifier: NCT00053365     History of Changes
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 27, 2009