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Trastuzumab Plus R115777 in Treating Patients with Advanced or Metastatic Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Trastuzumab Plus R115777 in Treating Patients with Advanced or Metastatic Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Trastuzumab Plus R115777 in Treating Patients with Advanced or Metastatic Cancer Clinical research trials and Trastuzumab Plus R115777 in Treating Patients with Advanced or Metastatic Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Trastuzumab Plus R115777 in Treating Patients with Advanced or Metastatic Cancer. Trastuzumab Plus R115777 in Treating Patients with Advanced or Metastatic Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Trastuzumab Plus R115777 in Treating Patients with Advanced or Metastatic Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Trastuzumab Plus R115777 in Treating Patients with Advanced or Metastatic Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Trastuzumab Plus R115777 in Treating Patients with Advanced or Metastatic Cancer  Trastuzumab Plus R115777 in Treating Patients with Advanced or Metastatic Cancer
Trastuzumab Plus R115777 in Treating Patients with Advanced or Metastatic Cancer
For Condition: Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , University of Texas
Synopsis: RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with R115777 may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of R115777 when administered with trastuzumab (Herceptin) in patients with advanced or metastatic adenocarcinoma. II. Assess the toxicities and pharmacokinetics of this treatment regimen in this patient population. III. Determine the antitumor activity of this treatment regimen in these patients. IV. Determine the relative biologic endpoints of this regimen and correlate them with toxicity and pharmacokinetic parameters in these patients. PROTOCOL OUTLINE: This is a dose escalation, multicenter study of R115777. Patients receive trastuzumab (Herceptin) IV over 90 minutes on days 1, 8, 15, and 22 plus oral R115777 twice daily for 3 weeks. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities. Patients are followed every 30 days until toxicity resolves. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study over 24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed advanced or metastatic adenocarcinoma; Expression of +1 to 3+ HER2/neu on immunohistochemical or immunocytochemistry staining - No brain metastases unless all of the following is true; Previously treated; Asymptomatic; Stable dose of decadron; No evidence of edema - Hormonal receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: No prior trastuzumab (Herceptin); No other concurrent immunotherapy - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) and recovered; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal cancer therapy except LHRH agonists for prostate cancer - Radiotherapy: No concurrent radiotherapy - Surgery: Not specified - Other: No other concurrent experimental medications --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.0 g/dL - Hepatic: Bilirubin no greater than 1.5 mg/dL; AST/ALT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver involvement) - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: LVEF at least 50% by RVG or MUGA; No uncontrolled unstable angina; No history of congestive heart failure or cardiac ischemia - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No concurrent active infection or serious systemic disorder that would preclude study; No allergies to imidazole compounds
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnthonyTolcher, Study Chair, University of Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
Institute for Drug Development
San Antonio, Texas, 78245-3217
United States
Additional Information:
Study ID Numbers: CDR0000067858; UTHSC-IDD-99-26,NCI-62,SACI-IDD-99-26
Study Start Date: June 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005842
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Trastuzumab Plus R115777 in Treating Patients with Advanced or Metastatic Cancer
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