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A Phase I Study Of SU5416 With Androgen Ablation And Radiation In Patients With Intermediate and Advanced Stage Prostate Cancer

Phase 1
Not Enrolling
Prostate Cancer

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Trial Information

A Phase I Study Of SU5416 With Androgen Ablation And Radiation In Patients With Intermediate and Advanced Stage Prostate Cancer

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.

Inclusion 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Side effects of SU5416 in combination with standard hormone treatment and radiation in men with prostate cancer

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Walter M. Stadler, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

November 2001

Completion Date:

April 2003

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



University of Chicago Cancer Research Center Chicago, Illinois  60637
LaGrange Memorial Hospital LaGrange, Illinois  60525
Radiation Oncology Chicago, Illinois  60612