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A Phase II Trial of SU5416 (NSC# 686819) in Patients With Hormone Refractory Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase II Trial of SU5416 (NSC# 686819) in Patients With Hormone Refractory Prostate Cancer


OBJECTIVES:

- Compare the time to progression in patients with hormone refractory prostate cancer
treated with dexamethasone with or without SU5416.

- Determine the differences in PSA kinetics and PSA hazard score between these two
regimens in this patient population.

- Determine the objective response rate and time to development of new lesions in these
patients treated with SU5416.

- Determine the toxicity of SU5416 in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

- Arm I: Patients receive oral dexamethasone once a day 6 days a week. Treatment
continues until disease progression, at which time patients cross over to arm II.

- Arm II: Patients receive oral dexamethasone as in arm I followed by SU5416 IV over 60
minutes twice weekly for 4 weeks. A smaller dose of dexamethasone is administered the
day after SU5416. Treatment continues for a minimum of 2 courses in the absence of
unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within
16 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed prostate cancer not amenable to curative treatment with
surgery or radiotherapy

- Progressive disease defined by 1 of the following criteria:

- New bone scan lesions

- New or progressive radiologic lesions

- Sequential increases in PSA on at least 2 successive measurements no less than 2
weeks apart of at least 50% above nadir on prior therapy provided absolute value
at time of enrollment is at least 5 ng/mL

- Progressive disease, as defined above, despite adequate hormonal therapy defined by
all of the following:

- Continued treatment with an LHRH agonist or prior orchiectomy

- Sequential or concurrent treatment with an antiandrogen (e.g., flutamide,
nilutamide, or bicalutamide)

- Trial of antiandrogen withdrawal at least 4 weeks prior to study

- CNS metastasis allowed if:

- Previously treated

- Neurologically stable

- Oral or intravenous steroids or anticonvulsants not required

- Brain scan (CT or MRI) within the past 2 weeks shows no active or residual
disease

- Negative brain scan required if neurologic signs or symptoms suggestive of
CNS metastasis

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- WHO 0-1

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 75,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- Transaminases no greater than 2.5 times upper limit of normal

Renal:

- Creatinine no greater than 2.0 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No uncompensated coronary artery disease

- No history of myocardial infarction or severe unstable angina within the past 6
months

- No severe peripheral vascular disease associated with diabetes mellitus

- No deep venous or arterial thrombosis within the past 3 months

Pulmonary:

- No pulmonary embolism within the past 3 months

Other:

- Not pregnant

- Fertile patients must use effective contraception

- No significant uncontrolled underlying medical or psychiatric illness

- No serious active infection

- No other prior or concurrent malignancy except nonmelanoma skin cancer unless
completed therapy and considered to be at less than 30% risk of relapse

- No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior systemic chemotherapy

- No other concurrent chemotherapy

- No other concurrent investigational antineoplastic drugs

Endocrine therapy:

- See Disease Characteristics

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior major surgery

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Walter M. Stadler, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

10428

NCT ID:

NCT00006002

Start Date:

June 2000

Completion Date:

January 2006

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Loyola University Medical CenterMaywood, Illinois  60153
Ingalls Memorial HospitalHarvey, Illinois  60426
Evanston Northwestern Health CareEvanston, Illinois  60201
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
University of Illinois at ChicagoChicago, Illinois  60612
Cancer Care Specialists of Central Illinois, S.C.Decatur, Illinois  62526
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Central Illinois Hematology Oncology CenterSpringfield, Illinois  62701
Fort Wayne Medical Oncology and Hematology, Inc.Fort Wayne, Indiana  46885-5099
Michiana Hematology/Oncology P.C.South Bend, Indiana  46617
Oncology Care Associates, P.L.L.C.Saint Joseph, Michigan  49085
Division of Hematology/OncologyPark Ridge, Illinois  60068
City of Hope Medical GroupPasadena, California  91105
LaGrange Memorial HospitalLaGrange, Illinois  60525