NCT00024063

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2001

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

April 6, 2004

Completed
Last Updated

December 19, 2013

Status Verified

April 1, 2007

First QC Date

September 13, 2001

Last Update Submit

December 18, 2013

Conditions

Breast CancerColorectal CancerGastric CancerKidney CancerLung CancerMultiple Myeloma and Plasma Cell NeoplasmPancreatic CancerProstate Cancer

Keywords

stage III colon cancerstage IV colon cancerstage IV breast cancerstage IIIA breast cancerrecurrent breast cancerstage III gastric cancerstage IV gastric cancerrecurrent gastric cancerstage IIIB breast cancerrecurrent non-small cell lung cancerstage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic cancerstage III rectal cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerrefractory multiple myelomastage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancerstage III multiple myelomastage III prostate cancerstage IV prostate cancerrecurrent prostate cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancermale breast cancerstage IV pancreatic cancer

Interventions

orantinibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsStomach NeoplasmsKidney NeoplasmsLung NeoplasmsMultiple MyelomaNeoplasms, Plasma CellPancreatic NeoplasmsProstatic NeoplasmsColonic NeoplasmsCarcinoma, Non-Small-Cell LungRectal NeoplasmsCarcinoma, Renal CellBreast Neoplasms, Male

Interventions

orantinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesStomach DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and Epithelial

Study Officials

  • Lee S. Rosen, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2001

First Posted

April 6, 2004

Last Updated

December 19, 2013

Record last verified: 2007-04