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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00080782

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer Prostate Cancer	Drug: Celecoxib Drug: Doxorubicin Hydrochloride Radiation: Strontium chloride Sr 89	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2002

Actual Primary Completion Date :

Apr 1, 2004

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Arm

Intervention/Treatment

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 Names:

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

Outcome Measures

Primary Outcome Measures

Time to prostate-specific antigen progression [Continuous assessment 16 weeks of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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)