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| Tracking Information | |||||
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| First Received Date ICMJE | December 10, 1999 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | March 1996 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004030 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin | ||||
| Official Title ICMJE | A Phase I/II Study of the Pharmacokinetics, Tolerability and Safety of Administration of VX-853 to Patients Receiving Single Agent Therapy With Doxorubicin HCI | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. 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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Unspecified Adult Solid Tumor, Protocol Specific | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 45 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically proven relapsed or incurable solid tumors No primary or metastatic CNS disease PATIENT CHARACTERISTICS: See General Eligibility Criteria 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 |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004030 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000065641, GUMC-96007, VX-95-853-001, VX-GUMC-96007, NCI-V97-1275 | ||||
| Study Sponsor ICMJE | Lombardi Cancer Research Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | January 2001 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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