- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00036751
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Texas
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San Antonio, Texas, United States, 78245
- Southwest Oncology Group (SWOG) Research Base
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate (complete and partial confirmed response)
Time Frame: Up to 3 years
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity as assessed by NCI Common Toxicity Criteria version 2.0
Time Frame: Up to 3 years
|
Up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Alberts, Southwest Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
Other Study ID Numbers
- NCI-2012-02463
- U10CA032102 (U.S. NIH Grant/Contract)
- SWOG-S0211
- CDR0000069319 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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