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Imatinib Mesylate in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00036751
First received: May 13, 2002
Last updated: January 23, 2013
Last verified: January 2013

May 13, 2002
January 23, 2013
April 2002
August 2007   (final data collection date for primary outcome measure)
Response rate (complete and partial confirmed response) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00036751 on ClinicalTrials.gov Archive Site
Toxicity as assessed by NCI Common Toxicity Criteria version 2.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Imatinib Mesylate in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
A Phase II Trial Of STI571 For The Treatment Of Platinum And Taxane Refractory Stage III And IV Epithelial Ovarian Cancer And Primary Peritoneal Cancer

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer that has not responded to previous treatment. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth

OBJECTIVES:

I. Determine the response rates (confirmed, complete, and partial) in patients with platinum- and taxane-refractory stage III or IV ovarian epithelial or primary peritoneal cancer treated with imatinib mesylate.

II. Determine the toxicity of this drug in these patients. III. Correlate, preliminarily, CD117 and platelet-derived growth factor receptor expression levels with response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Drug: imatinib mesylate
    Given orally
    Other Names:
    • CGP 57148
    • Gleevec
    • Glivec
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: imatinib mesylate
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Not Provided
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed epithelial carcinoma of the ovary or primary peritoneal serous papillary carcinoma

    • No mixed Mullerian tumors
    • No borderline ovarian tumors
  • Stage III or IV disease at time of diagnosis by surgical staging
  • Expression of KIT (CD117) and/or platelet-derived growth factor receptor by immunohistochemistry
  • Relapsed within 6 months after completion of or progressed while receiving prior frontline chemotherapy with a platinum (cisplatin or carboplatin) and a taxane(paclitaxel or docetaxel) administered concurrently or sequentially
  • Measurable disease
  • Performance status - Zubrod 0-1
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusion allowed)
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2.5 times ULN
  • Creatinine no greater than 1.5 times ULN
  • No New York Heart Association class III or IV heart disease (e.g., congestive heart failure or myocardial infarction within the past 2 months)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study participation
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
  • At least 28 days since prior biologic therapy
  • No concurrent anticancer biologic therapy
  • No concurrent cytokines (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
  • At least 28 days since prior chemotherapy
  • No more than 3 prior chemotherapy regimens in addition to frontline chemotherapy

    • Retreatment with a platinum agent or with the same taxane as in the frontline regimen is not counted as an additional regimen
  • No concurrent chemotherapy
  • Prior hormonal therapy allowed
  • Recovered from prior radiotherapy
  • No prior radiotherapy to more than 25% of bone marrow
  • No concurrent radiotherapy
  • Prior surgical debulking allowed for relapsed disease if measurable disease remains after surgery
  • At least 14 days since prior major surgery
  • Recovered from all prior surgery
  • At least 28 days since prior investigational drugs
  • No concurrent therapeutic doses of warfarin for anticoagulation (heparin or mini-dose warfarin (1 mg/day) allowed)
  • No other concurrent anticancer agents
  • No other concurrent investigational drugs
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00036751
NCI-2012-02463, SWOG-S0211, U10CA032102, CDR0000069319
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: David Alberts Southwest Oncology Group
National Cancer Institute (NCI)
January 2013

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