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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| 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: | Treatment, Randomized, Active Control |
| 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 |
| Estimated Enrollment: | 70 |
| Study Start Date: | February 2002 |
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
| Study ID Numbers: | CDR0000355360, MDA-ID-02035 |
| Study First Received: | April 7, 2004 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00080782 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent prostate cancer stage IV prostate cancer bone metastases |
|
Anti-Inflammatory Agents Celecoxib Genital Neoplasms, Male Prostatic Diseases Cyclooxygenase Inhibitors Urogenital Neoplasms Genital Diseases, Male Recurrence Doxorubicin |
Anti-Bacterial Agents Analgesics, Non-Narcotic Neoplasm Metastasis Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Prostatic Neoplasms Androgens |
|
Anti-Inflammatory Agents Prostatic Diseases Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Antibiotics, Antineoplastic Neoplastic Processes Neoplasms by Site Pathologic Processes Sensory System Agents Therapeutic Uses Neoplasm Metastasis |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Celecoxib Cyclooxygenase Inhibitors Enzyme Inhibitors Genital Diseases, Male Doxorubicin Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Prostatic Neoplasms |
