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

This study has been terminated.
(Low accrual due to competing trial.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00080782
First received: April 7, 2004
Last updated: July 27, 2012
Last verified: August 2010
  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 2

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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Time to prostate-specific antigen progression [ Time Frame: Continuous assessment 16 weeks of treatment ] [ Designated as safety issue: No ]

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:
  • Adriamycin
  • Rubex
Radiation: Strontium chloride Sr 89
IV on day 1
Other Names:
  • Sr-89
  • Metastron
  • Strontium-89
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:
  • Adriamycin
  • Rubex
Radiation: Strontium chloride Sr 89
IV on day 1
Other Names:
  • Sr-89
  • Metastron
  • Strontium-89

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080782

Locations
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Shi-Ming Tu, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. 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: July 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Neoplasm Metastasis
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms
Androgens
Celecoxib
Doxorubicin
Liposomal doxorubicin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antibiotics, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2014