Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	Any age	NCI	MDA-ID-00156 NCI-3410, 3410, NCT00024167

Special Category: CTSU trial

Objectives

1. Compare the effectiveness, in terms of overall survival, of consolidation therapy with or without strontium chloride Sr 89 after induction chemotherapy in patients with androgen-independent prostate cancer.

Entry Criteria

Disease Characteristics:

• Diagnosis of adenocarcinoma of the prostate
  • No small cell carcinoma
• Androgen-independent
  • No evidence of response after either of the following anti-androgen withdrawal periods:
    • Within 4 weeks for flutamide
    • Within 6 weeks for bicalutamide or nilutamide
• Rising prostate-specific antigen (PSA) (at least 5 ng/mL) on at least 2 occasions at least 1 week apart AND bone pain OR worsening bone scan with new lesions in less than 6 months
• Castrate testosterone level no greater than 50 ng/mL (must continue treatment to maintain castrate levels)
• No symptomatic lymphadenopathy (scrotal or pedal edema) or significant local invasive disease (hematuria)
• Osteoblastic metastases on bone scan or CT scan
• No predominant visceral metastases to liver, lungs, or brain

Prior/Concurrent Therapy:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered
• Prior angiogenesis inhibitors and gene therapy allowed

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• No prior doxorubicin or vinblastine for patients receiving induction chemotherapy with KAVE (ketoconazole, doxorubicin, vinblastine, estramustine)
• No prior docetaxel for patients receiving induction chemotherapy with prednisone plus docetaxel

Endocrine therapy:

• See Disease Characteristics
• Prior secondary hormonal agents (e.g., aminoglutethimide, diethylstilbestrol, or estramustine) allowed
• Prior steroid therapy (e.g., dexamethasone, prednisone, or hydrocortisone) allowed

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered
• No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium

Surgery:

• No prior vagotomy

Other:

• No more than 1 prior cytotoxic regimen

Patient Characteristics:

Age:

• Any age

Performance status:

• Zubrod 0-3

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC greater than 3,000/mm³
• Absolute neutrophil count greater than 1,500/mm³
• Platelet count greater than 100,000/mm³

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST and ALT no greater than 2 times ULN

Renal:

• Not specified

Cardiovascular:

• No transient ischemic attack or myocardial infarction within the past 12 months
• No active angina or claudication sufficient to limit activity
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other:

• Fertile patients must use effective contraception
• No prior allergic reaction to compounds of similar biologic or chemical composition to study drugs
• No other conditions (e.g., pernicious anemia) associated with achlorhydria
• No other active malignancy or malignancy that is likely to become active except non-melanoma skin cancer
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study participation
• No other uncontrolled concurrent illness that would preclude study participation

Expected Enrollment

Approximately 480 patients (240 randomized) will be accrued for this study within 48 months.

Outcomes

Overall survival

Outline

This is a randomized study. Patients are stratified according to type of induction chemotherapy (KAVE vs prednisone and docetaxel), number of bony metastases (no more than 20 vs more than 20), ECOG performance status (0-1 vs 2-3), and use of zoledronate (yes vs no).

• Induction therapy: Patients receive 1 of 2 induction therapy regimens.
  • Regimen A (KAVE): Patients receive doxorubicin IV over 24 hours on day 1 and oral ketoconazole three times daily on days 1-7 of weeks 1, 3, and 5. Patients receive vinblastine IV over 30 minutes on day 1 and oral estramustine three times daily on days 1-7 of weeks 2, 4, and 6. Patients receive no treatment on weeks 7 and 8. Treatment repeats every 8 weeks for at least 2 courses* in the absence of disease progression or unacceptable toxicity.

     [Note: *Patients continue to receive oral ketoconazole three times daily until disease progression.]

  • Regimen B (prednisone and docetaxel): Patients receive oral prednisone twice daily on days 1-21 (days 1-14 of course 5 only) and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for at least 5 courses in the absence of disease progression or unacceptable toxicity.

• Consolidation therapy: Patients with a prostate-specific antigen (PSA) response (at least 50% decline in PSA level from baseline at week 16 OR at least 2 PSA levels decreased at least 50% from baseline) are randomized to 1 of 2 consolidation treatment arms.
  • Arm I: Patients receive doxorubicin IV over 24 hours once weekly for 6 weeks plus strontium chloride Sr 89 IV once at the beginning of chemotherapy.
  • Arm II: Patients receive doxorubicin as in arm I.

Patients are followed every 4 weeks until PSA progression and then every 3 months thereafter.

Tu SM, Kim J, Pagliaro LC, et al.: Therapy tolerance in selected patients with androgen-independent prostate cancer following strontium-89 combined with chemotherapy. J Clin Oncol 23 (31): 7904-10, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Shi-Ming Tu, MD, Protocol chair		Ph: 713-563-7268; 800-392-1611

U.S.A.
Georgia
	Gainesville
	Northeast Georgia Medical Center
		Richard LoCicero, MD	Ph:  770-297-5700
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute	Ph:  912-350-8568
Illinois
	Chicago
	Resurrection Medical Center
		Christopher Rose, MD	Ph:  847-965-3200
	Hines
	Veterans Affairs Medical Center - Hines
		Nirmala Bhoopalam, MD	Ph:  708-202-2782
	Rockford
	Swedish-American Regional Cancer Center
		Clinical Trials Office - Swedish-American Regional Cancer Center	Ph:  815-489-4413
Iowa
	Bettendorf
	Hematology Oncology Associates of the Quad Cities
		Shobha Chitneni, MD, MBBS	Ph:  563-355-7733
	Davenport
	Genesis Regional Cancer Center at Genesis Medical Center
		George Kovach, MD	Ph:  563-421-1960
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-0088
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Ralph Vance	Ph:  601-984-5590
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
	CCOP - Montana Cancer Consortium
		Benjamin Marchello, MD	Ph:  406-238-6290
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290
	Northern Rockies Radiation Oncology Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	St. Vincent Healthcare Cancer Care Services
		Benjamin Marchello, MD	Ph:  406-238-6290
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Butte
	St. James Healthcare Cancer Care
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls
		Benjamin Marchello, MD	Ph:  406-238-6290
	Big Sky Oncology
		Clinical Trail Office - Big Sky Oncology	Ph:  406-731-8217
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-238-6290
	Sletten Cancer Institute at Benefis Healthcare
		Grant Harrer, MD, FACP, CCTI	Ph:  406-731-8100
	Helena
	St. Peter's Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Medical Oncology at KRMC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Missoula
	Community Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Guardian Oncology and Center for Wellness
		Benjamin Marchello, MD	Ph:  406-238-6290
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Ph:  406-329-7029
	Montana Cancer Specialists at Montana Cancer Center
		Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center	Ph:  406-238-6962
Nebraska
	Kearney
	Good Samaritan Cancer Center at Good Samaritan Hospital
		Clinical Trials Office - Good Samaritan Cancer Center at Good Samaritan Hospital	Ph:  308-865-7963
North Carolina
	Goldsboro
	Southeastern Medical Oncology Center - Goldsboro
		James Atkins, MD	Ph:  919-580-0000
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
Ohio
	Akron
	Summa Center for Cancer Care at Akron City Hospital
		Clinical Trials Office - Akron City Hospital	Ph:  330-375-6101
	Barberton
	Barberton Citizens Hospital
		William Demas, MD	Ph:  330-375-3557
	Salem
	Cancer Care Center, Incorporated
		William Demas, MD	Ph:  330-375-3557
	Wooster
	Cancer Treatment Center
		Clinical Trials Office - Cancer Treatment Center	Ph:  330-375-4221
South Carolina
	Florence
	McLeod Regional Medical Center
		Clinical Trials Office - McLeod Regional Medical Center	Ph:  843-679-7256
Texas
	Dallas
	Medical City Dallas Hospital
		Barry Mirtsching, MD	Ph:  972-566-5588
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
Wyoming
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290

Registry Information
Official Title		A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy with or Without Stronium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer
Trial Start Date		2001-10-29
Trial Completion Date		2004-08-14 (estimated)
Registered in ClinicalTrials.gov		NCT00024167
Date Submitted to PDQ		2001-07-13
Information Last Verified		2009-11-06
NCI Grant/Contract Number		CA16672, CA45809

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