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Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00041041
  Purpose

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have persistent or recurrent ovarian epithelial or primary peritoneal cancer.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: imatinib mesylate
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Imatinib Imatinib mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Evaluation Of Gleevec (Imatinib Mesylate) (IND #61135, NSC #716051) In The Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma

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

Study Start Date: June 2002
Detailed Description:

OBJECTIVES:

  • Determine the cytostatic antitumor activity of imatinib mesylate, in terms of 6-month progression-free survival, in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma.
  • Determine the frequency and severity of adverse effects of this drug in these patients.
  • Determine the distribution of overall and progression-free survival in patients treated with this drug.
  • Determine the clinical response rate (partial response and complete response) in patients treated with this drug.
  • Determine the effects of this drug on initial performance status, platinum sensitivity, and mucinous (or clear cell) histology in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 4-15 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
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

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • Tumors within a previously irradiated field considered nontarget lesions
  • At least one prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or another organoplatinum compound) for primary disease required

    • Initial treatment may include high-dose, consolidation, or extended therapy
    • Initial treatment-free interval less than 12 months for patients who received only 1 prior platinum-based regimen
    • Initial treatment-free interval of more than 12 months allowed provided disease progression has occurred within 12 months after retreatment with a second-line platinum-based regimen
  • Ineligible for a higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • GOG 0-2 (if patient has received one prior treatment regimen)
  • GOG 0-1 (if patient has received two prior treatment 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/SGPT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study participation
  • No active infection requiring antibiotics
  • No greater than grade 1 sensory and motor neuropathy
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No signs or symptoms of bowel dysfunction

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior immunologic therapy directed at the malignant tumor
  • No concurrent biologic therapy or immunotherapy for the malignant tumor

Chemotherapy:

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No prior noncytotoxic chemotherapy for persistent or recurrent disease
  • One additional cytotoxic regimen for persistent or recurrent disease allowed
  • No concurrent chemotherapy for the malignant tumor

Endocrine therapy:

  • At least 1 week since prior hormonal therapy directed at the malignant tumor
  • No concurrent therapeutic corticosteroids
  • No concurrent anticancer hormonal therapy
  • Concurrent hormone replacement therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • No prior radiotherapy to more than 25% of marrow-bearing areas
  • No concurrent anticancer radiotherapy

Surgery:

  • Recovered from recent prior surgery

Other:

  • At least 3 weeks since other prior therapies directed at the malignant tumor
  • No prior imatinib mesylate
  • No prior anticancer therapy that would preclude study participation
  • No concurrent therapeutic anticoagulation with warfarin
  • No other concurrent investigational drugs
  • No concurrent amifostine or other protective reagents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041041

Locations
United States, California
Women's Cancer Center at Community Hospital of Los Gatos
Los Gatos, California, United States, 95032
United States, Illinois
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103-1489
United States, New York
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States, 11790-7775
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1065
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44124
Ireland Cancer Center
Cleveland, Ohio, United States, 44106
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001-3788
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104-4283
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, Vermont
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, United States, 05401
United States, Washington
Tacoma General Hospital
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Russell J. Schilder, MD Fox Chase Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000069438, GOG-0170E
Study First Received: July 8, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00041041  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Ovarian cancer
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Abdominal Neoplasms
Recurrence
Carcinoma
Imatinib
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009