SU006668 in Treating Patients With Advanced Solid Tumors
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Colorectal Cancer Gastric Cancer Kidney Cancer Lung Cancer Multiple Myeloma and Plasma Cell Neoplasm Pancreatic Cancer Prostate Cancer |
Drug: orantinib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study Of SU006668 Via Twice Daily Oral Administration Under Fed Conditions In Patients With Advanced Malignancies |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00024063 History of Changes |
| Other Study ID Numbers: | CDR0000068888, UCLA-0004061, SUGEN-SU6668.004, NCI-G01-2010 |
| Study First Received: | September 13, 2001 |
| Last Updated: | November 12, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Colorectal Neoplasms Lung Neoplasms Stomach Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Pancreatic Neoplasms Prostatic Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013