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Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
This study has been completed.
Study NCT00041041   Information provided by National Cancer Institute (NCI)
First Received: July 8, 2002   Last Updated: February 5, 2009   History of Changes

July 8, 2002
February 5, 2009
June 2002
January 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00041041 on ClinicalTrials.gov Archive Site
 
 
 
Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
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

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.

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.

Phase II
Interventional
Treatment, Open Label
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
Drug: imatinib mesylate
 
Schilder RJ, Sill MW, Lee RB, Shaw TJ, Senterman MK, Klein-Szanto AJ, Miner Z, Vanderhyden BC. Phase II evaluation of imatinib mesylate in the treatment of recurrent or persistent epithelial ovarian or primary peritoneal carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2008 Jul 10;26(20):3418-25.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
January 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00041041
 
CDR0000069438, GOG-0170E
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Russell J. Schilder, MD Fox Chase Cancer Center
National Cancer Institute (NCI)
September 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP