Overview
VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin
Status:
Completed
Completed
Trial end date:
2001-01-01
2001-01-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Georgetown UniversityCollaborator:
National Cancer Institute (NCI)Treatments:
Doxorubicin
Liposomal doxorubicin
Criteria
DISEASE CHARACTERISTICS: Histologically proven relapsed or incurable solid tumors Noprimary 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