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

Alternate Title

Doxorubicin and Strontium-89 With or Without Celecoxib in Treating Patients With Progressive Androgen-Independent Prostate Cancer and Bone Metastases

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Any age	NCI	MDA-ID-02035 NCT00080782

Special Category: SPORE trial

Objectives

1. Compare time to prostate-specific antigen progression in patients with progressive androgen-independent prostate cancer and bone metastases treated with doxorubicin and strontium chloride Sr 89 with or without celecoxib.

Entry Criteria

Disease Characteristics:

• Diagnosis of androgen-independent prostate cancer
  • Osteoblastic metastases
  • No predominant visceral metastases
• Progressive disease after response to prior induction chemotherapy (prostate-specific antigen decline of at least 50% from baseline after 16 weeks of treatment)
• No symptomatic lymphadenopathy (i.e., scrotal or pedal edema)

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• No prior radionuclide therapy

Surgery

• Not specified

Other

• No more than 3 prior cytotoxic treatments
• More than 6 months since prior celecoxib or rofecoxib

Patient Characteristics:

Age

• Any age

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Adequate physiologic reserves

Expected Enrollment

A total of 70 patients (35 per treatment arm) will be accrued for this study within 18 months.

Outcomes

Time to prostate-specific antigen progression

Outline

This is a randomized study. Patients are stratified according to extent of bone metastases on bone scan (> 20 lesions vs ≤ 20 lesions) and quality of response (i.e., decline of the prostate-specific antigen from baseline) to prior induction chemotherapy (≥ 80% vs < 80%). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 and strontium chloride Sr 89 IV on day 1. Patients also receive oral celecoxib twice daily in the absence of disease progression.
• Arm II: Patients receive doxorubicin and strontium chloride Sr 89 as in arm I.

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

Registry Information
Official Title		A Randomized Phase II Trial of Bone-Targeted Therapy Consisting of Strontium-89 and Doxorubicin with or without Celecoxib in Androgen-Independent Prostate Cancer
Trial Start Date		2002-02-20
Registered in ClinicalTrials.gov		NCT00080782
Date Submitted to PDQ		2003-10-20
Information Last Verified		2006-10-13
NCI Grant/Contract Number		CA16672, CA90270

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