SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
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.
Drug: goserelin acetate
Drug: leuprolide acetate
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study Of SU5416 With Androgen Ablation And Radiation In Patients With Intermediate and Advanced Stage Prostate Cancer|
- Side effects of SU5416 in combination with standard hormone treatment and radiation in men with prostate cancer [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2001|
|Study Completion Date:||April 2003|
|Primary Completion Date:||March 2002 (Final data collection date for primary outcome measure)|
Experimental: SU5416 in combination with hormone and radiation therapy
Subjects receive 5 months of hormone suppression therapy consisting of 1 month of Bicalutamide or Flutamide followed by 4 months of leuprolide or goserlin injections. After completion of at least 12 weeks of hormone therapy, subjects will receive 7 1/2 weeks of radiation therapy. SU5416 will be given by IV infusion starting 4 weeks before beginning radiation treatment and continuing until 4 weeks after completion of radiation. Multiple doses of SU5416 will be studied.
50 mg daily for 1 monthDrug: flutamide
250 mg 3 times daily for 1 monthDrug: goserelin acetate
3.6 mg once a month for 4 monthsDrug: leuprolide acetate
7.5 mg once a month for 4 monthsDrug: SU5416
IV infusion at assigned doseRadiation: radiation therapy
daily for 5 days each week
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026377
|United States, Illinois|
|Chicago, Illinois, United States, 60612|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|LaGrange Memorial Hospital|
|LaGrange, Illinois, United States, 60525|
|Study Chair:||Walter M. Stadler, MD, FACP||University of Chicago|