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Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy
This study is ongoing, but not recruiting participants.
First Received: October 11, 2001   Last Updated: November 19, 2009   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025155
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy.


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

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Evaluation Of Epothilone-B BMS 247550 (IND # 59,669 NSC # 710428) In The Treatment Of Recurrent Or Persistent Platinum And Paclitaxel Refractory Ovarian Or Primary Peritoneal Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Frequency and duration of objective response [ Designated as safety issue: No ]
  • Frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]
  • Survival time [ Designated as safety issue: No ]
  • Duration of progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: July 2002
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer.
  • Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: Patients receive ixabepilone IV over 1 hour. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 6-12 months.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial cancer or primary peritoneal cancer

    • Recurrent or persistent disease
    • Platinum AND taxane-resistant or refractory disease

      • Progressed during therapy OR
      • Refractory disease within 6 months of therapy
  • Measurable disease

    • At least 20 mm by conventional techniques
    • At least 10 mm by spiral CT scan
    • Tumor lesions located within a previously irradiated field are not considered measurable disease unless there is documented tumor progression in these lesions or biopsy confirmation ≥ 90 days following completion of radiotherapy
  • Ineligible for higher priority GOG protocol
  • No active brain metastases

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal:

  • Creatinine ≤ 1.5 times ULN

Neurologic:

  • No sensory or motor neuropathy > grade 1
  • No dementia or altered mental status

Other:

  • No other serious uncontrolled medical disorder
  • No active infection requiring antibiotics
  • No prior hypersensitivity reaction to paclitaxel or other therapy containing Cremophor EL
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior biologic therapy
  • At least 3 weeks since prior immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • Must have received:

    • 1 prior combination taxane-based and platinum-based chemotherapy regimen OR
    • 1 prior platinum-based chemotherapy regimen AND 1 prior taxane-based chemotherapy regimen
  • Initial treatment may include high-dose therapy, consolidation, or extended therapy
  • At least 3 weeks since prior chemotherapy and recovered
  • No prior ixabepilone
  • No other prior cytotoxic chemotherapy for recurrent or persistent disease, including treatment with initial regimen

Endocrine therapy:

  • At least 1 week since prior hormonal anticancer therapy
  • Concurrent hormone replacement therapy allowed

Radiotherapy:

  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to site(s) of measurable disease
  • No radiotherapy to > 25% of marrow-containing areas

Surgery:

  • Recovered from recent surgery

Other:

  • At least 3 weeks since other anticancer therapy
  • No prior anticancer therapy that precludes study participation
  • No concurrent food supplements (e.g., St. John's wort)
  • No concurrent amifostine or other protective agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025155

  Hide Study Locations
Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
Doctors Medical Center
Modesto, California, United States, 95350-4138
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Todd Cancer Institute at Long Beach Memorial Medical Center
Long Beach, California, United States, 90801
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Colorado
Colorado Gynecologic Oncology Group P.C.
Aurora, Colorado, United States, 80010
United States, Connecticut
George Bray Cancer Center at New Britain General Hospital
New Britain, Connecticut, United States, 06050
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
United States, District of Columbia
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States, 32504
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Louisville Oncology at Norton Cancer Center
Louisville, Kentucky, United States, 40202
United States, Maryland
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Nebraska
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Mount Carmel West Hospital
Columbus, Ohio, United States, 43222
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: David R. Spriggs, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068927, GOG-0126M
Study First Received: October 11, 2001
Last Updated: November 19, 2009
ClinicalTrials.gov Identifier: NCT00025155     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Digestive System Neoplasms
Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Epothilones
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases
Abdominal Neoplasms
Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Digestive System Diseases
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Peritoneal Diseases
Peritoneal Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009