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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 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor Clinical research trials and Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor. Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor clinical trial. Test subjects typically obtain the finest healthcare available for their Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor  Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor
Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor
For Condition: Fallopian Tube Cancer,peritoneal cavity cancer,recurrent ovarian epithelial cancer,ovarian low malignant potential tumor
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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 relapsedovarian epithelial, fallopian tube, or primaryperitoneal cancer, or ovarian low malignant potential tumor.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EliseKohn, Study Chair, National Cancer Institute (NCI)
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 1-888-NCI-1937
Center for Cancer Research *Recruiting*
Bethesda, Maryland, 20892-1906
United States
Recruiting Virginia Kwitkowski 301-402-5640
Additional Information:
Study ID Numbers: CDR0000069403; NCI-02-C-0190,NCI-5672A
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039585
Other Peritoneal Cavity Cancer Studies:
1. Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer
2. Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
3. Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer
4. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer
5. Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Related Studies:
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Other Bethesda Clinical Trials
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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