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A PHASE III STUDY OF THREE DIFFERENT DOSES OF SURAMIN (NSC #34936) ADMINISTERED WITH A FIXED DOSING SCHEDULE IN PATIENTS WITH ADVANCED PROSTATE CANCER


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A PHASE III STUDY OF THREE DIFFERENT DOSES OF SURAMIN (NSC #34936) ADMINISTERED WITH A FIXED DOSING SCHEDULE IN PATIENTS WITH ADVANCED PROSTATE CANCER


OBJECTIVES:

I. Compare the response in patients with advanced hormone-refractory adenocarcinoma of the
prostate treated with low- vs intermediate- vs high-dose suramin.

II. Compare the toxic effects of these regimens in these patients. III. Compare the overall
and failure-free survival of patients treated with these regimens.

IV. Compare the duration of complete and partial responses in patients treated with these
regimens.

V. Determine the population pharmacokinetics of these regimens and correlate these
parameters with the toxicity of these regimens and response rate in these patients.

VI. Compare the quality of life of patients treated with these regimens. VII. Determine the
relationship of absolute and relative decrease in PSA and rate of PSA decrease with the
likelihood and duration of response in patients treated with these regimens.

VIII. Determine whether a change in fibroblast growth factor levels in patients treated with
suramin can be associated with the pharmacokinetics of suramin or the likelihood of clinical
response in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease site (bone only vs soft tissue), CALGB/Zubrod performance status (0 or 1 vs 2),
number of prior hormonal therapies (1 or 2 vs 3), and participating center. Patients are
randomized to 1 of 3 treatment arms.

Arm I: Patients receive low-dose suramin IV over 1 hour on days 1, 2, 8, 9, 29, 30, 36, 37,
57, 58, 64, and 65 in the absence of disease progression or unacceptable toxicity.

Arm II: Patients receive intermediate-dose suramin as in arm I.

Arm III: Patients receive high-dose suramin as in arm I. Patients with new progression after
partial or complete response may receive additional courses, at the discretion of the study
chairperson, beginning at least 12 weeks after completion of the first course and continuing
in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed.

Patients are followed every 4 weeks until disease progression and then periodically for new
primary cancer(s) and survival.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven adenocarcinoma of the prostate with progressive metastatic or
progressive regional nodal disease

- PSA evidence of progression defined as at least 50% increase over baseline on at
least 2 measurements at least 2 weeks apart

- Measurable disease preferred but not required

- Bone scan abnormalities acceptable provided PSA at least 10 ng/mL

- No minimum PSA value required if measurable disease present

- Progression after or during an adequate trial of hormonal therapy

- No more than 3 prior hormonal interventions for progressive disease

- One prior hormonal intervention is defined by any of the following:

- Concurrent testicular and adrenal androgen ablation (e.g., leuprolide,
goserelin, orchiectomy, or diethylstilbestrol (DES) plus flutamide,
bicalutamide, nilutamide, megestrol, or other antiandrogen)

- Initial LHRH agonist followed by orchiectomy provided no progression prior
to orchiectomy

- Prior intermittent androgen deprivation on protocol SWOG-9346

- Corticosteroids for metastatic disease or in conjunction with
aminoglutethimide or ketoconazole

- Two prior hormonal interventions are defined by the following:

- Antiandrogen given for disease progression more than 3 months after initial
hormonal therapy

- Prior neoadjuvant or adjuvant deprivation for treatment of nonmetastatic disease not
considered a prior hormonal intervention

- Antiandrogen withdrawal not considered a separate hormonal intervention

- At least 4 weeks since antiandrogen withdrawal or megestrol withdrawal

- Failure to respond to (i.e., no decrease in PSA at 2 and 4 weeks) or progression
after a transient response to antiandrogen withdrawal or megestrol withdrawal
required

- Primary testicular androgen suppression (e.g., LHRH agonist or DES) continues during
study

- No brain metastases or other CNS disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- CALGB 0-2 OR

- Zubrod 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- WBC at least 3,000/mm3

- Absolute neutrophil count at least 1,200/mm3

- Platelet count at least 100,000/mm3

- Hemoglobin at least 9 g/dL

- Fibrinogen at least 200 mg/dL

- No prior hemorrhagic or thrombotic disorders

Hepatic:

- Bilirubin normal

- AST/ALT no greater than 2.5 times normal

- Prothrombin time, partial thromboplastin time, and thrombin time normal

Renal:

- Creatinine clearance at least 70 mL/min

Other:

- No primary muscle disease

- No active, uncontrolled bacterial, viral, or fungal infection

- No grade 1 or worse peripheral neuropathy

- No underlying medical condition that would preclude study

- No other serious medical illness that limits survival to less than 3 months

- No psychiatric condition that would preclude informed consent

- No other malignancy within the past 5 years except inactive nonmelanomatous skin
cancer or adequately treated stage I or II cancer in remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy for metastatic disease

Chemotherapy:

- No prior chemotherapy (including estramustine) for metastatic disease

Endocrine therapy:

- No concurrent megestrol or other hormonal agents

- No concurrent systemic or inhaled corticosteroids (intranasal and topical steroids
allowed)

Radiotherapy:

- At least 4 weeks since prior radiotherapy (8 weeks for strontium therapy)

Other:

- No prior experimental therapy for metastatic disease

- No concurrent heparin, warfarin, or aspirin

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response

Outcome Description:

PSA levels

Outcome Time Frame:

Week 12 and then monthly

Safety Issue:

No

Principal Investigator

Eric J. Small, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02788

NCT ID:

NCT00002723

Start Date:

January 1996

Completion Date:

March 2008

Related Keywords:

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

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Ireland Cancer CenterCleveland, Ohio  44106-5065
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
CCOP - DuluthDuluth, Minnesota  55805
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Medical College of WisconsinMilwaukee, Wisconsin  53226
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville CampusNashville, Tennessee  37212