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Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
imatinib mesylate
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer, borderline ovarian surface epithelial-stromal tumor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer OR Histologically confirmed ovarian low malignant potential tumor with invasive recurrence Relapsed after and/or refractory to platinum- and taxane-based chemotherapy Patients in first relapse after a disease-free interval of more than 1 year are eligible Measurable disease outside prior radiation field Availability of a sentinel lesion that is adequate for core biopsy through percutaneous biopsy or simple laparoscopic means Patients with clinical evidence of CNS involvement (abnormal clinical examination) must have a negative CT scan with contrast or MRI of the brain No large volume ascites or pleural effusion PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count greater than 1,500/mm^3 Hemoglobin at least 9.0 g/dL (independent of epoetin alfa or transfusion) Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No myocardial infarction or unstable dysrhythmia within the past 6 months No congestive heart failure (CHF), including CHF that may be compensated with furosemide Other: No other invasive malignancy within the past 5 years except noninvasive nonmelanoma skin cancer No active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after study completion Concurrent residual, stable, grade 2 or lower peripheral neuropathy allowed at the discretion of the principal investigator (PI) PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior signal transduction therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or carboplatin) Endocrine therapy: At least 4 weeks since prior hormonal therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: Recovered from prior anticancer therapy At least 1 week since prior antibiotics No more than 4 prior anticancer regimens No concurrent ketoconazole, itraconazole, erythromycin, or clarithromycin No concurrent therapeutic warfarin Patients who can be safely converted over to low molecular weight heparin are eligible No concurrent grapefruit or grapefruit juice No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent alternative or complementary therapies or over-the-counter agents unless approved by the PI Concurrent medications that may alter the metabolism of imatinib mesylate and lead to potential toxicity are allowed at the discretion of the PI

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • NCI - Center for Cancer Research

Outcomes

Primary Outcome Measures

Clinical response in patients with epithelial ovarian cancer as measured by CT scan of chest, abdomen, and pelvis every 8 weeks

Secondary Outcome Measures

Corr. of biochem. modulation of signal transduction pathways downstream of platelet-derived growth factor receptor (PDGFR) and c-kit tyrosine kinase by tumor lysate microarray analysis in biopsy tissue with patient outcome at baseline and at 4 wks
Correlation of PDGFR and c-kit expression with response and outcome in patients with epithelial ovarian cancer as measured by tumor microarray analysis on biopsy tissue at baseline and at 4 weeks
Antiangiogenic activity as measured by tumor lysate microarray on biopsy tissue at baseline and at 4 weeks
Collateral receptor tyrosine kinase inhibition as measured by tumor lysate microarray on biopsy tissue at baseline and at 4 weeks
Prediction of response and/or toxicity as measured by Surface-Enhanced Laser Desorption/Ionization Time-Of-Flight (SELDI-TOF) proteomics and Artificial Intelligence bioinformatics on serum samples at baseline and every 4 wks

Full Information

First Posted
June 6, 2002
Last Updated
April 29, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00039585
Brief Title
Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor
Official Title
Phase II Clinical Trial With Proteomic Profiling Of Imatinib Mesylate (Gleevec; STI571), A PDGFR And C-Kit Inhibitor, In Patients With Refractory Or Relapsed Epithelial Ovarian Cancer, Fallopian Tube And Primary Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to determine the effectiveness of imatinib mesylate in treating patients who have refractory or relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer, or ovarian low malignant potential tumor.
Detailed Description
OBJECTIVES: Determine the clinical activity of imatinib mesylate in patients with recurrent or relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer or ovarian low malignant potential tumor. Correlate the biochemical modulation of signal transduction pathways downstream of platelet-derived growth factor receptor (PDGFR) and c-kit tyrosine kinases in biopsy tissue with outcome in patients treated with this drug. Correlate the expression of PDGFR and c-kit in both archival and fresh biopsy tissue with response and outcome in patients treated with this drug. Investigate the potential antiangiogenic activity of this drug in microdissected tumor cell and stromal lysates of these patients. Investigate the potential for collateral receptor tyrosine kinase inhibition in biopsy tissue of patients treated with this drug. Evaluate the application of surface-enhanced laser desorption and ionization with time-of-flight detection (SELDI-TOF) with artificial intelligence bioinformatics to serially obtained serum samples for prediction of response in these patients and/or toxicity of this drug. OUTLINE: Patients receive oral imatinib mesylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: Up to 47 patients will be accrued for this study within 12-20 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer, borderline ovarian surface epithelial-stromal tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Primary Outcome Measure Information:
Title
Clinical response in patients with epithelial ovarian cancer as measured by CT scan of chest, abdomen, and pelvis every 8 weeks
Secondary Outcome Measure Information:
Title
Corr. of biochem. modulation of signal transduction pathways downstream of platelet-derived growth factor receptor (PDGFR) and c-kit tyrosine kinase by tumor lysate microarray analysis in biopsy tissue with patient outcome at baseline and at 4 wks
Title
Correlation of PDGFR and c-kit expression with response and outcome in patients with epithelial ovarian cancer as measured by tumor microarray analysis on biopsy tissue at baseline and at 4 weeks
Title
Antiangiogenic activity as measured by tumor lysate microarray on biopsy tissue at baseline and at 4 weeks
Title
Collateral receptor tyrosine kinase inhibition as measured by tumor lysate microarray on biopsy tissue at baseline and at 4 weeks
Title
Prediction of response and/or toxicity as measured by Surface-Enhanced Laser Desorption/Ionization Time-Of-Flight (SELDI-TOF) proteomics and Artificial Intelligence bioinformatics on serum samples at baseline and every 4 wks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer OR Histologically confirmed ovarian low malignant potential tumor with invasive recurrence Relapsed after and/or refractory to platinum- and taxane-based chemotherapy Patients in first relapse after a disease-free interval of more than 1 year are eligible Measurable disease outside prior radiation field Availability of a sentinel lesion that is adequate for core biopsy through percutaneous biopsy or simple laparoscopic means Patients with clinical evidence of CNS involvement (abnormal clinical examination) must have a negative CT scan with contrast or MRI of the brain No large volume ascites or pleural effusion PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count greater than 1,500/mm^3 Hemoglobin at least 9.0 g/dL (independent of epoetin alfa or transfusion) Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No myocardial infarction or unstable dysrhythmia within the past 6 months No congestive heart failure (CHF), including CHF that may be compensated with furosemide Other: No other invasive malignancy within the past 5 years except noninvasive nonmelanoma skin cancer No active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after study completion Concurrent residual, stable, grade 2 or lower peripheral neuropathy allowed at the discretion of the principal investigator (PI) PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior signal transduction therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or carboplatin) Endocrine therapy: At least 4 weeks since prior hormonal therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: Recovered from prior anticancer therapy At least 1 week since prior antibiotics No more than 4 prior anticancer regimens No concurrent ketoconazole, itraconazole, erythromycin, or clarithromycin No concurrent therapeutic warfarin Patients who can be safely converted over to low molecular weight heparin are eligible No concurrent grapefruit or grapefruit juice No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent alternative or complementary therapies or over-the-counter agents unless approved by the PI Concurrent medications that may alter the metabolism of imatinib mesylate and lead to potential toxicity are allowed at the discretion of the PI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elise C. Kohn, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Virginia Kwitkowski, MS, RN, CS, CRNP
Organizational Affiliation
National Cancer Institute (NCI)
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
NCI - Center for Cancer Research
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1906
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Hussain M, Kotz H, Minasian L, et al.: Occurrence of ascites secondary to STI571 in ovarian cancer patients . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-880, 2003.
Results Reference
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Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor

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