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Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Clinical research trials and Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer. Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer clinical trial. Human subjects often get the best healthcare available for their Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer  Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
For Condition: Ovarian Neoplasms,Pelvic Neoplasms,Peritoneal Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will evaluate the safety and effectiveness of the experimental drug imatinib (Gleevec, previously known as ST1571) for treating patients with advanced ovarian cancer with or without fallopian tube or primary peritoneal cancer. Gleevec is approved for patients with chronic myeloid leukemia and has shown activity against other leukemias and stomach and intestinal tumors. Its effect on ovarian cancer is not known. Patients with relapsed ovarian cancer or ovarian cancer that does not respond to platinum and taxane-based chemotherapy may be eligible for this study. Patients with fallopian tube or primary peritoneal cancer are also eligible. Candidates will be screened with a medical history, physical examination and computerized tomography (CT) scan or ultrasound to locate the tumor and determine biopsy sites. All participants will undergo tumor biopsies (described below). Participants will take Gleevec capsules twice a day. Patients whose tumors shrink or remain stable without serious side effects may continue to receive treatment. Those whose cancers worsen or who develop severe drug side effects will be taken off the study and counseled about alternative treatments. Patients will have a CT scan or ultrasound study before starting treatment and again every 8 weeks. They will have a needle biopsy or laparoscopy of the tumor before starting treatment and again about 4 weeks into the study to look for characteristics unique to the patient's tumor that might make it more likely to respond to Gleevec. A limited CT of the tumor will be done at the time of the second biopsy. For the biopsy, the area of the procedure is anesthetized and a small needle is inserted through the skin into the tumor. A piece of tissue smaller than the size of a pin is withdrawn through the needle. Laparoscopy is a surgical procedure performed under general anesthesia. It requires making two small holes in the skin through which tubes are inserted to locate the tumor and cut out a small piece of tissue. Patients will have follow-up visits every 4 weeks, or more often as needed, for a physical examination and blood tests, and review of laboratory studies and drug side effects. Blood tests will be done weekly for the first month of follow-up.
Details: This is a phase II study with exploratory endpoints to determine clinical activity of imatinib mesylate (STI571; Gleevec), an inhibitor of Abl, PDGFR and c-kit tyrosine kinases, in patients with epithelial ovarian cancer, fallopian tube and primary peritoneal cancer. This study will evaluate the regulation of signal transduction pathways downstream of PDGFR and c-kit in vivo pre- and post-treatment using imatinib mesylate. Exploratory objectives include evaluation of a correlation between tumor signal pathway profiles and patient outcome with PDGFR and c-kit expression; the possibility of collateral cross-talk inhibition between pro-survival pathways downstream of other tyrosine kinase receptor such as EGFR by inhibition of PDGFR and c-kit in vivo; and the role of PDGFR and c-kit inhibition in modulating tumor angiogenesis in vivo. The application of SELDI-TOF with artificial intelligence bioinformatics to serially obtained serum samples for prediction of response and/or toxicity will be explored as well.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA: All patients must have biopsy-proven, epithelial ovarian cancer, relapsed and/or refractory to platinum and taxane-based chemotherapy. Patients with fallopian tube and/or primary peritoneal cancer, or low malignant potential tumor with invasive recurrence will also be eligible. For a first relapse, patients with a disease free interval greater than 12 months may be enrolled only after full informed consent outlining alternative treatment is obtained. Histopathologic diagnosis must be confirmed in the LP, National Cancer Institute and confirmation is necessary prior to entry. A block or unstained re-cuts of the primary tumor or a recent resection specimen is required for entry. All patients must have measurable disease to be eligible. All patients must have a sentinel lesion adequate for core biopsy either through percutaneous biopsy or simple laparoscopic means. The lesion must not be in a prior radiation field. Patients must have a performance status: ECOG = 0, 1 or 2. Patients must have good end organ function: WBC greater than or equal to 3000/mm(3), ANC greater than 1500/mm(3), hemoglobin greater than or equal to 9.0 (independent of erythropoietin or transfusion), platelets greater than or equal to 100,000/mm(3), normal acute care panel with serum creatinine less than or equal to 1.5 mg/dl, transaminases less than or equal to 2.5 times the upper limit of normal and bilirubin less than or equal to 1.5 mg/dl. Patients must be at least 4 weeks from prior therapy (chemotherapy, hormonal therapy, signal transduction therapy and radiation therapy). Mitomycin and carboplatin must have been stopped at least 6 weeks prior to enrollment. No concomitant use of alternative, complementary therapies or over the counter agents will be allowed without approval of the PI. Every effort will be made to maximize patient safety and minimize changes in chronic medications. Medications that may alter metabolism of imatinib mesylate and lead to potential toxicity will be allowed at the discretion of the PI. Number of prior regimens is restricted to four given the risk of marrow toxicity with imatinib mesylate. All patients must have recovered from prior toxicity to NCI/CTEP grade 1 or better. Patients with residual, stable grade 2 peripheral neuropathy may be enrolled at the discretion of the PI. Imatinib mesylate causes abortions and is potentially teratogenic at high doses in rabbits and rats. The compound is therefore not suitable for administration to pregnant women, and conception while on therapy should be avoided. In women of childbearing potential, contraception should continue for 3 months after the last dose of imatinib mesylate to allow the complete clearance of drug and its principal metabolites from the body. Since interactions with the metabolism of oral contraceptives cannot be excluded at present, a barrier method of contraception must be used. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with imatinib mesylate, breastfeeding should be discontinued if the mother is treated with imatinib mesylate. Patients must be able to give written informed consent. All patients must be registered by calling the ORKAND Corporation at 301-402-1732 between the hours of 8:30 AM and 5:00 PM EST. EXCLUSION CRITERIA: Clinical evidence of CNS involvement (abnormal clinical exam) will require a head CT with contrast or MRI). Patients receiving ketoconazole, itraconazole, erythromycin, or clarithromycin will be excluded unless an alternative drug can be prescribed. Patients on therapeutic doses of warfarin will be excluded due to potential drug interactions with imatinib mesylate and increased risk of serious hemorrhage. These patients may be included if they can be safely converted over to low molecular weight heparin. History of myocardial infarction or unstable dysrhythmia within six months of study entry. Patients in congestive heart failure will be excluded given a greater risk of fluid retention with imatinib mesylate. This includes patients who may be compensated with furosemide. History of another invasive malignancy within the last five years. Noninvasive, non-melanoma skin cancers will be allowed. Patients with active infection will not be eligible, but may be reconsidered once the infection has resolved. Patients must be at least 7 days from completion of antibiotics. HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with imatinib mesylate or other agents administered during the study.
Total Enrollment: 47
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Virginia Kwitkowski 3014025640
Additional Information:
Study ID Numbers: 020190; 02-C-0190
Study Start Date: May 3, 2002
Record last reviewed: January 28, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035646
Other Pelvic Neoplasms Studies:
1. Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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