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VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin Clinical research trials and VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin. VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin clinical trial. Test subjects oftentimes recieve the best healthcare possible for their VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin  VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin
VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Lombardi Cancer Research Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of VX-853 in treating patients who have solid tumors who are receiving liposomal doxorubicin.
Details: OBJECTIVES: I. Determine the safety and tolerability of VX-853 in combination with doxorubicin HCl liposome in patients with relapsed or incurable solid tumors. II. Obtain pharmacokinetic profiles for various dosages of VX-853 administered in combination with doxorubicin HCl liposome. III. Achieve whole blood concentrations of VX-853 in the predicted therapeutically effective range and characterize the pharmacokinetics at these doses. IV. Document antitumor effects of VX-853 in combination with doxorubicin HCl liposome in these patients. PROTOCOL OUTLINE: This is a dose escalation study of VX-853. Patients receive VX-853 orally every 8 hours on days 1-3 and doxorubicin HCL liposome IV over approximately 15 minutes beginning 26 hours after starting VX-853. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of VX-853 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose limiting toxicity. PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within approximately 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven relapsed or incurable solid tumors - No primary or metastatic CNS disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 3 weeks since prior cytotoxic chemotherapy (6 weeks since prior mitomycin or nitrosourea); Prior doxorubicin HCl allowed (no extensive therapy) - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Prior surgery allowed - Other: Recovered from toxic effects of prior therapy; At least 4 weeks since prior investigational or approved clinical trial agents; No concurrent cimetidine, phenothiazines, phenytoin, calcium channel blockers, or cyclosporine or other P-glycoprotein inhibitors --Patients Characteristics-- - Age: 18 and over - Performance Status: Karnofsky 70-100% - Life Expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Hemoglobin at least 9.0 g/dL; Platelet count at least 100,000/mm3 - Hepatic: AST and/or ALT no greater than 2 times upper limit of normal; Bilirubin normal - Renal: Creatinine normal; Creatinine clearance at least 60 mL/min - Cardiovascular: No clinically significant EKG abnormalities; No atrial or ventricular arrhythmias requiring medication; No ischemic event within 6 months of study; Cardiac ejection fraction at least 50% by MUGA scan - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No prior or concurrent seizure disorders; No prior or concurrent clinically significant medical illness; No known hypersensitivity to doxorubicin HCl or other study medications; No other active malignancies except curatively treated carcinoma in situ of the cervix or basal cell skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelHawkins, Study Chair, Lombardi Cancer Research Center
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington D.C., District of Columbia, 20007
United States
Additional Information:
Study ID Numbers: CDR0000065641; GUMC-96007,NCI-V97-1275,VX-95-853-001,VX-GUMC-96007
Study Start Date: March 1996
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004030
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. GPX-100 in Treating Patients With Solid Tumors
2. LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function
3. UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors
4. Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors
5. Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin
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