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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00080782 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer Prostate Cancer |
Drug: Celecoxib Drug: Doxorubicin Hydrochloride Radiation: Strontium chloride Sr 89 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 14 |
| Study Start Date: | February 2002 |
| Study Completion Date: | January 2005 |
| Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I: Celecoxib
Doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 + Strontium chloride Sr 89 IV on day 1, and oral celecoxib twice daily in absence of disease progression.
|
Drug: Celecoxib
Oral celecoxib twice daily in the absence of disease progression.
Other Name: Celebrex
Drug: Doxorubicin Hydrochloride
By vein (IV) over 30 minutes on days 1, 8, 15, and 22
Other Names:
Radiation: Strontium chloride Sr 89
IV on day 1
Other Names:
|
|
Experimental: Arm II: No Celecoxib
Doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 + Strontium chloride Sr 89 IV on day 1.
|
Drug: Doxorubicin Hydrochloride
By vein (IV) over 30 minutes on days 1, 8, 15, and 22
Other Names:
Radiation: Strontium chloride Sr 89
IV on day 1
Other Names:
|
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this study within 18 months.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of androgen-independent prostate cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Texas | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Shi-Ming Tu, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Tu, Shi-Ming, M.D., UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00080782 History of Changes |
| Other Study ID Numbers: | ID02-035, P50CA090270, P30CA016672, MDA-ID-02035, CDR0000355360 |
| Study First Received: | April 7, 2004 |
| Last Updated: | August 17, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent prostate cancer stage IV prostate cancer bone metastases Progressive Androgen-Independent Prostate Cancer Metastron Sr-89 Strontium-89 |
strontium chloride Sr 89 Celecoxib Celebrex Doxorubicin Rubex Adriamycin |
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Prostatic Neoplasms Neoplastic Processes Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Androgens Doxorubicin Celecoxib Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
