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

NCT ID: NCT00080782

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2005-01-31

Brief Summary

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.

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.

Conditions

Metastatic Cancer; Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

Oral celecoxib twice daily in the absence of disease progression.

Doxorubicin Hydrochloride

Intervention Type: DRUG

By vein (IV) over 30 minutes on days 1, 8, 15, and 22

Strontium chloride Sr 89

Intervention Type: RADIATION

IV on day 1

Arm II: No Celecoxib

Doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 + Strontium chloride Sr 89 IV on day 1.

Group Type: EXPERIMENTAL

Doxorubicin Hydrochloride

Intervention Type: DRUG

By vein (IV) over 30 minutes on days 1, 8, 15, and 22

Strontium chloride Sr 89

Intervention Type: RADIATION

IV on day 1

Interventions

Celecoxib

Oral celecoxib twice daily in the absence of disease progression.

Intervention Type: DRUG

Doxorubicin Hydrochloride

By vein (IV) over 30 minutes on days 1, 8, 15, and 22

Intervention Type: DRUG

Strontium chloride Sr 89

IV on day 1

Intervention Type: RADIATION

Other Intervention Names

Celebrex; Adriamycin; Rubex; Sr-89; Metastron; Strontium-89

Eligibility Criteria

Inclusion 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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shi-Ming Tu, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

UT MD Anderson Cancer Center Website

Other Identifiers

P50CA090270

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MDA-ID-02035

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000355360

Identifier Type: REGISTRY

Identifier Source: secondary_id

ID02-035

Identifier Type: -

Identifier Source: org_study_id