|
BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors Clinical research trials and BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors. BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors  BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors
BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Suspended
Sponsor(s): National Cancer Institute (NCI) , Fox Chase Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of BMS-214662 plus trastuzumab in treating patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of BMS-214662 when combined with trastuzumab (Herceptin) in patients with advanced solid tumors. II. Determine the dose-limiting toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine, in a preliminary manner, the antitumor activity of this regimen in these patients. PROTOCOL OUTLINE: This is a dose-escalation study of BMS-214662. Patients receive BMS-214662 IV over 1 hour on days 2, 8, 15, and 22 and trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with BMS-214662 and trastuzumab at the recommended phase II dose. PROJECTED ACCRUAL: A total of 3-28 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective therapy exists Overexpressing HER-2-neu (2+ or 3+) by immunohistochemistry or fluorescent in situ hybridization Clinically or radiologically evaluable disease No carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease - At least 8 weeks since prior therapy for prior brain parenchymal disease and asymptomatic off corticosteroids --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since prior immunotherapy, including trastuzumab (Herceptin), and recovered Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No anthracyclines for at least 22 weeks after completion of study therapy - No other concurrent chemotherapy Endocrine therapy: - See Disease Characteristics - Concurrent hormone replacement therapy allowed - No other concurrent hormonal therapy Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered - No prior radiotherapy to more than 25% of the bone marrow-containing skeleton - No concurrent radiotherapy Surgery: Not specified Other: - At least 4 weeks since prior investigational agents and recovered - At least 7 days since prior known substrates of cytochrome P450-3A4 (CYP3A4) - At least 7 days since prior parenteral antibiotics - No concurrent substrates of CYP3A4 - No concurrent parenteral antibiotics - No other concurrent experimental medications --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.8 mg/dL - ALT and AST no greater than 1.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: - No uncontrolled or significant cardiovascular disease - No myocardial infarction within the past 6 months - No prior clinically significant atrial or ventricular arrhythmias - No prior second or third degree heart block - No ischemic heart disease requiring medication - No congestive heart failure - Corrected QT interval no greater than 450 milliseconds by electrocardiogram - Ejection fraction at least lower limit of normal by MUGA scan Pulmonary: No uncontrolled or significant pulmonary disease Other: - No active unresolved infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaryCianfrocca, Study Chair, Fox Chase Cancer Center
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Additional Information:
Study ID Numbers: CDR0000068828; FCCC-01013,NCI-139
Study Start Date: October 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022529
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Fenretinide in Treating Patients With Solid Tumors
2. Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors
3. Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors
4. Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors
5. UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors
|
|
|
|
|
|
|
|
