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Doxorubicin and Strontium-89 With or Without Celecoxib in Treating Patients With Progressive Androgen-Independent Prostate Cancer and Bone Metastases
This study is ongoing, but not recruiting participants.
Study NCT00080782   Information provided by National Cancer Institute (NCI)
First Received: April 7, 2004   Last Updated: February 6, 2009   History of Changes

April 7, 2004
February 6, 2009
February 2002
 
Time to prostate-specific antigen progression [ Designated as safety issue: No ]
Time to prostate-specific antigen progression
Complete list of historical versions of study NCT00080782 on ClinicalTrials.gov Archive Site
 
 
 
Doxorubicin and Strontium-89 With or Without Celecoxib in Treating Patients With Progressive Androgen-Independent Prostate Cancer and Bone Metastases
A Randomized Phase II Trial of Bone-Targeted Therapy Consisting of Strontium-89 and Doxorubicin With or Without Celecoxib in Androgen-Independent Prostate Cancer

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Strontium-89 may relieve bone pain caused by prostate cancer. Celecoxib may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Combining doxorubicin and strontium-89 with celecoxib may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying celecoxib together with doxorubicin and strontium-89 to see how well they work compared to doxorubicin and strontium-89 alone in treating patients with progressive androgen-independent prostate cancer and bone metastases.

OBJECTIVES:

  • 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.

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.

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

Phase II
Interventional
Treatment, Randomized, Active Control
  • Metastatic Cancer
  • Prostate Cancer
  • Drug: celecoxib
  • Drug: doxorubicin hydrochloride
  • Radiation: strontium chloride Sr 89
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
70
 
 

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)

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

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
Male
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00080782
 
CDR0000355360, MDA-ID-02035
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Shi-Ming Tu, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP