Patient Abstract available in the near future.

Condition	Treatment or Intervention	Phase
Lung Cancer Pancreatic Cancer Gastric Cancer Renal Cell Cancer Colorectal Cancer Colon Cancer Prostate Cancer Rectal Cancer Breast Cancer Multiple Myeloma kidney tumor	Drug: SU6668	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the maximum tolerated dose of SU006668 in patients with advanced solid tumors. II. Determine the pharmacokinetics of this drug in these patients. III. Determine the objective response of patients treated with this drug. IV. Determine the toxic effects of this drug in these patients.

PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive oral SU006668 twice daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 6 to 12 patients receive escalating doses of SU006668 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 or 4 of 12 patients experience dose-limiting toxicity. Patients are followed at 30 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Study chairs or principal investigators

Lee S. Rosen,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068888; UCLA-0004061; NCI-G01-2010; SUGEN-SU6668.004
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  September 13, 2001
ClinicalTrials.gov Identifier:  NCT00024063
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08