NCT Number: NCT00039585
Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor
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.
Looking for future studies?
Notify MeKey information
Conditions
Sex eligibility
Female
Study type
Interventional
Phase
Phase 2
Primary location
NCI - Center for Cancer Research, Bethesda, Maryland, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Clinical response in patients with epithelial ovarian cancer as measured by CT scan of chest, abdomen, and pelvis every 8 weeks
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
National Cancer Institute (NCI)
Nih
Registry information
Official study 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
Important dates
- Study start
- 2002
- Primary completion
- 2006
- First posted
- Jan 27, 2003
- Registry last updated
- Apr 30, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Pazopanib Hydrochloride, Paclitaxel, and Carboplatin in Treating Patients With Refractory or Resistant Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
NCT01402271
Adnexal Diseases, Carcinoma
Brussels, Belgium
View Trial DetailsVaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
NCT00066729
Adnexal Diseases, Carcinoma
New York, United States
View Trial DetailsAutologous T Cells With or Without Cyclophosphamide and Fludarabine in Treating Patients With Recurrent or Persistent Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer (Fludarabine Treatment Closed as of 12/01/2009)
NCT00562640
Adnexal Diseases, Carcinoma
New York, United States
View Trial DetailsCombination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
NCT00002600
Adnexal Diseases, Carcinoma
Baltimore, Maryland, United States
View Trial Details