Overview

SU006668 in Treating Patients With Advanced Solid Tumors

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs such as SU006668 may stop the growth of solid tumors by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of SU006668 in treating patients who have advanced solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Orantinib
Criteria
DISEASE CHARACTERISTICS: Diagnosis of one of the following advanced malignancies: Breast
Colorectal Non-small cell lung Gastric Pancreatic Renal Prostate Myeloma Failed standard
therapy OR No effective standard therapy exists Measurable or evaluable disease No known
CNS metastases Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Male or female Menopausal status: Not
specified Performance status: Karnofsky 60-100% Life expectancy: Not specified
Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL AST and
ALT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL
OR Creatinine clearance at least 40 mL/min Cardiovascular: No myocardial infarction or
severe/unstable angina within the past 6 months No evidence of uncompensated coronary
artery disease by electrocardiogram or physical exam Other: No other malignancy within the
past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No
insulin-dependent diabetes mellitus No non-insulin-dependent diabetes mellitus with
clinical evidence of severe peripheral vascular disease or diabetic ulcers No manifestation
of malabsorption due to prior surgery, GI disease, or unknown reasons No active
inflammatory bowel disease No known intolerance to any excipients in the study drug
formulation No other acute or chronic medical or psychiatric condition or laboratory
abnormality that would preclude study Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior anticancer
biologic or immunotherapy and recovered No prior SU006668 No other concurrent immunotherapy
Chemotherapy: At least 4 weeks since prior anticancer chemotherapy (6 weeks for
nitrosoureas or mitomycin) and recovered No concurrent chemotherapy Endocrine therapy: At
least 4 weeks since prior hormonal therapy No concurrent hormonal therapy except for
hormonal contraception or appetite stimulation Radiotherapy: Recovered from prior
radiotherapy Surgery: At least 6 weeks since prior surgery At least 6 months since prior
coronary/peripheral artery bypass graft surgery Prior major GI surgery allowed if no
residual syptomatic manifestation of malabsorption No prior organ transplantation Other: At
least 4 weeks since prior investigational agents No other concurrent investigational agents