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SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bicalutamide
flutamide
goserelin acetate
leuprolide acetate
SU5416
radiation therapy
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Radiation Oncology
  • University of Chicago Cancer Research Center
  • LaGrange Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SU5416 in combination with hormone and radiation therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 9, 2001
Last Updated
September 4, 2013
Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00026377
Brief Title
SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Official Title
A Phase I Study Of SU5416 With Androgen Ablation And Radiation In Patients With Intermediate and Advanced Stage Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
April 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SU5416 in combination with hormone and radiation therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bicalutamide
Intervention Description
50 mg daily for 1 month
Intervention Type
Drug
Intervention Name(s)
flutamide
Intervention Description
250 mg 3 times daily for 1 month
Intervention Type
Drug
Intervention Name(s)
goserelin acetate
Intervention Description
3.6 mg once a month for 4 months
Intervention Type
Drug
Intervention Name(s)
leuprolide acetate
Intervention Description
7.5 mg once a month for 4 months
Intervention Type
Drug
Intervention Name(s)
SU5416
Intervention Description
IV infusion at assigned dose
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
daily for 5 days each week
Primary Outcome Measure Information:
Title
Side effects of SU5416 in combination with standard hormone treatment and radiation in men with prostate cancer
Time Frame
24 weeks

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter M. Stadler, MD, FACP
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
Radiation Oncology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
LaGrange Memorial Hospital
City
LaGrange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States

12. IPD Sharing Statement

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SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

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