Clinical trial NCT00024063: SU006668 in Treating Patients With Advanced Solid Tumors
Official title: A Phase I Study Of SU006668 Via Twice Daily Oral Administration Under Fed Conditions In Patients With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Breast Cancer
Colorectal Cancer
Gastric Cancer
Kidney Cancer
Lung Cancer
Multiple Myeloma and Plasma Cell Neoplasm
Pancreatic Cancer
Prostate Cancer
Keywords: stage III colon cancer
stage IV colon cancer
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage III gastric cancer
stage IV gastric cancer
recurrent gastric cancer
stage IIIB breast cancer
recurrent non-small cell lung cancer
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
refractory multiple myeloma
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
stage III multiple myeloma
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
male breast cancer
stage IV pancreatic cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-04-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Lee S. Rosen, MD
role: STUDY_CHAIR
References: