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SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00026377
  Purpose

RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, bicalutamide, leuprolide, or goserelin may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining SU5416, hormone therapy, and radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of SU5416 plus hormone therapy and radiation therapy in treating patients who have prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: flutamide
Drug: goserelin
Drug: leuprolide acetate
Drug: semaxanib
Procedure: radiation therapy
Phase I

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Semaxanib Goserelin Leuprolide acetate Leuprolide Flutamide Bicalutamide SU 5416
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study Of SU5416 With Androgen Ablation And Radiation In Patients With Intermediate and Advanced Stage Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2001
Detailed Description:

OBJECTIVES: I. Determine the safety of SU5416 in combination with standard androgen ablation and radiotherapy in patients with intermediate or advanced-stage prostate cancer.

OUTLINE: This is a multicenter, dose-escalation study of SU5416. Patients receive oral bicalutamide once daily or oral flutamide three times daily for at least 1 month followed by leuprolide or goserelin subcutaneously once monthly for four months. Beginning after the fourth administration of leuprolide or goserelin, patients undergo radiotherapy 5 days a week for 7-8 weeks. Beginning one month before radiotherapy and continuing until 1 month after radiotherapy, patients receive SU5416 IV over 60 minutes on days 1 and 4. Treatment repeats weekly in the absence of disease progression or unacceptable toxicity. Cohorts of 3-12 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 3 of 12 patients experience dose-limiting toxicity. Patients are followed every 4-6 weeks for 4 months and then every 8-12 weeks for 8 months.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate with at least 1 of the following: Clinical stage T2b or greater Gleason score at least 8 Pretreatment PSA greater than 15 ng/mL Pelvic and/or periaortic node(s) positive on abdominal/pelvic CT scan Metastatic disease requiring palliation for local symptoms No known brain metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No symptomatic congestive heart failure No cardiac arrhythmia No uncompensated coronary artery disease on ECG or physical exam No myocardial infarction or severe unstable angina within the past 6 months No deep venous or arterial thrombosis within the past 3 months Pulmonary: No pulmonary embolism within the past 3 months Other: No other concurrent uncontrolled illness No ongoing or active infection No diabetes mellitus with severe peripheral vascular disease No psychiatric illness or social condition that would preclude study No prior allergic reactions attributed to compounds of similar chemical or biological composition to SU5416 or Cremophor EL vehicle No prior severe allergic reactions to paclitaxel or docetaxel

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent anticancer chemotherapy Endocrine therapy: Prior hormonal therapy of any duration allowed Radiotherapy: No prior pelvic radiotherapy Surgery: No prior prostatectomy Other: No prior non-hormonal systemic therapy for prostate cancer No other concurrent investigational or commercial agents or therapies for malignancy No concurrent combination antiretroviral therapy for HIV-positive patients

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026377

Locations
United States, Illinois
LaGrange Memorial Hospital
LaGrange, Illinois, United States, 60525
Radiation Oncology
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Walter M. Stadler, MD, FACP University of Chicago
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069024, UCCRC-NCI-4390, NCI-4390
Study First Received: November 9, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00026377  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Leuprolide
Goserelin
Bicalutamide
Urogenital Neoplasms
Flutamide
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
SU 5416

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Fertility Agents, Female
Fertility Agents

ClinicalTrials.gov processed this record on January 15, 2009