Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer

NCT00002723 | Completed Phase 3 DMC

• 7 other identifiers: NCI-2012-02788U10CA031946CALGB-9480E-C9480SWOG-9452INT-0159CDR0000064583
• Study Type: interventional
• Target: 390
• Locations: 2 countries
• Sites: 27

Brief Summary

Randomized phase III trial to compare the effectiveness of low, intermediate, and high dose suramin in treating men with stage IV prostate cancer that is refractory to hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of suramin is more effective for prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage III prostate cancer; stage IV prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (2)

• Response

  PSA levels

  Week 12 and then monthly

• Response

  Radiographic evaluation

  Week 12 and every 12 weeks thereafter

Secondary Outcomes (3)

• Toxicity

  pre-study, day 1, then every 2 weeks during treatment and every 8 weeks during follow up

• Survival

  post treatment until patient expires

• Quality of Life

  pre-study, 2 weeks post treatment, and every 12 weeks in follow up

Study Arms (3)

Low dose suramin

EXPERIMENTAL

Low dose suramin

Drug: suramin

Intermediate dose suramin

EXPERIMENTAL

Intermediate dose suramin

Drug: suramin

High dose suramin

EXPERIMENTAL

High dose suramin

Drug: Suramin

Interventions

Suramin DRUG

3.192g/square meter total dose given decreasing concentrations in 250 cc normal saline IV over 1 hour on days 1,2,8,9,29,30,36,37,57,58,64,and 65.

Also known as: NSC #34936

Low dose suramin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• SWOG Cancer Research Network: collaborator
• Eastern Cooperative Oncology Group: collaborator

Study Sites (27)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, 60611, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07018-1095, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus

Nashville, Tennessee, 37212, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Veterans Affairs Medical Center - Madison

Madison, Wisconsin, 53705, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

CCOP - Marshfield Medical Research and Education Foundation

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, 53295, United States

Location

Pretoria Academic Hospitals

Pretoria, 0001, South Africa

Location

Related Publications (15)

• Halabi S, Vogelzang NJ, Kornblith AB, Ou SS, Kantoff PW, Dawson NA, Small EJ. Pain predicts overall survival in men with metastatic castration-refractory prostate cancer. J Clin Oncol. 2008 May 20;26(15):2544-9. doi: 10.1200/JCO.2007.15.0367.

  PMID: 18487572 BACKGROUND

• D'Amico AV, Halabi S, Vogelzang NJ, et al.: A reduction in the rate of PSA rise following chemotherapy in patients with metastatic hormone refractory prostate cancer (HRPC) predicts survival: results of a pooled analysis of CALGB HRPC trials. [Abstract] J Clin Oncol 22 (Suppl 14): A-4506, 383s, 2004.

  BACKGROUND

• Halabi S, Small EJ, Kantoff PW, Kattan MW, Kaplan EB, Dawson NA, Levine EG, Blumenstein BA, Vogelzang NJ. Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer. J Clin Oncol. 2003 Apr 1;21(7):1232-7. doi: 10.1200/JCO.2003.06.100.

  PMID: 12663709 BACKGROUND

• Gilligan TD, Halabi S, Kantoff PW, et al.: African-American race is associated with longer survival in patients with metastatic hormone-refractory prostate cancer (HRCaP) in four randomized phase III Cancer and Leukemia Group B (CALGB) trials. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-725, 2002.

  BACKGROUND

• George DJ, Halabi S, Shepard TF, Sanford B, Vogelzang NJ, Small EJ, Kantoff PW. The prognostic significance of plasma interleukin-6 levels in patients with metastatic hormone-refractory prostate cancer: results from cancer and leukemia group B 9480. Clin Cancer Res. 2005 Mar 1;11(5):1815-20. doi: 10.1158/1078-0432.CCR-04-1560.

  PMID: 15756004 RESULT

• Taplin ME, George DJ, Halabi S, Sanford B, Febbo PG, Hennessy KT, Mihos CG, Vogelzang NJ, Small EJ, Kantoff PW. Prognostic significance of plasma chromogranin a levels in patients with hormone-refractory prostate cancer treated in Cancer and Leukemia Group B 9480 study. Urology. 2005 Aug;66(2):386-91. doi: 10.1016/j.urology.2005.03.040.

  PMID: 16098367 RESULT

• Ahles TA, Herndon JE 2nd, Small EJ, Vogelzang NJ, Kornblith AB, Ratain MJ, Stadler W, Palchak D, Marshall ME, Wilding G, Petrylak D, Holland JC; Cancer and Leukemia Group B. Quality of life impact of three different doses of suramin in patients with metastatic hormone-refractory prostate carcinoma: results of Intergroup O159/Cancer and Leukemia Group B 9480. Cancer. 2004 Nov 15;101(10):2202-8. doi: 10.1002/cncr.20655.

  PMID: 15484217 RESULT

• Taplin ME, George DJ, Halabi S, et al.: Prognostic significance of plasma chromogranin A levels in hormone-refractory prostate cancer patients treated on Cancer and Leukemia Group B (CALGB) 9480. [Abstract] J Clin Oncol 22 (Suppl 14): A-4557, 396s, 2004.

  RESULT

• Small EJ, Halabi S, Ratain MJ, Rosner G, Stadler W, Palchak D, Marshall E, Rago R, Hars V, Wilding G, Petrylak D, Vogelzang NJ. Randomized study of three different doses of suramin administered with a fixed dosing schedule in patients with advanced prostate cancer: results of intergroup 0159, cancer and leukemia group B 9480. J Clin Oncol. 2002 Aug 15;20(16):3369-75. doi: 10.1200/JCO.2002.10.022.

  PMID: 12177096 RESULT

• Bok RA, Halabi S, Fei DT, Rodriquez CR, Hayes DF, Vogelzang NJ, Kantoff P, Shuman MA, Small EJ. Vascular endothelial growth factor and basic fibroblast growth factor urine levels as predictors of outcome in hormone-refractory prostate cancer patients: a cancer and leukemia group B study. Cancer Res. 2001 Mar 15;61(6):2533-6.

  PMID: 11289126 RESULT

• George DJ, Halabi S, Shepard TF, Vogelzang NJ, Hayes DF, Small EJ, Kantoff PW; Cancer and Leukemia Group B 9480. Prognostic significance of plasma vascular endothelial growth factor levels in patients with hormone-refractory prostate cancer treated on Cancer and Leukemia Group B 9480. Clin Cancer Res. 2001 Jul;7(7):1932-6.

  PMID: 11448906 RESULT

• Bok R, Halabi S, Shaal M, et al.: VEGF and basic FGF urine levels as predictors of response to therapy with suramin in CALGB 9480, a phase III study of hormone refractory prostate cancer (HRPC) patients. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A1367, 2000.

  RESULT

• Halabi S, Small EJ, Ansari RH, et al.: Results of CALGB 9480, a phase III trial of 3 different doses of suramin for the treatment of horomone refractory prostate cancer (HRPC). [Abstract] Proceedings of the American Society of Clinical Oncology 19: A1291, 2000.

  RESULT

• Kantoff P, Halabi S, Farmer D, et al.: RT-PCR for prostate specific antigen (PSA) in peripheral blood (PB) predicts survival duration in patients with hormone refractory prostate cancer (HRPC): a CALBG study. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A1323, 2000.

  RESULT

• Vogelzang N, Small E, Halabi R, et al.: A phase III trial of 3 different doses of suramin (SUR) in metastatic hormone refractory prostate cancer (HRPC): safety profile of CALGB 9480. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1339, 347a, 1998.

  RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Suramin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Naphthalenesulfonates; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Polycyclic Compounds

Study Officials

• Eric J. Small, MD

  University of California, San Francisco

  STUDY CHAIR

• Daniel P. Petrylak, MD

  Herbert Irving Comprehensive Cancer Center

  STUDY CHAIR

• George Wilding, MD

  University of Wisconsin, Madison

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: October 22, 2003
• Study Start: January 1, 1996
• Primary Completion: August 1, 2002
• Study Completion: March 1, 2008
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

US (26); ZA (1)