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

Phase 2

Terminated

• Conditions: Prostate Cancer; Metastatic Cancer
• Interventions: Drug: Celecoxib; Drug: Doxorubicin Hydrochloride; Radiation: Strontium chloride Sr 89

• Registration Number: NCT00080782
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2004-04
• Study First Submitted: 2004-04-07
• Study First Submitted QC: 2004-04-07
• Study First Posted: 2004-04-08
• Study Completion: 2005-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-30
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I: Celecoxib	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.
Arm I: Celecoxib	Doxorubicin Hydrochloride	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.
Arm I: Celecoxib	Strontium chloride Sr 89	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.
Arm II: No Celecoxib	Doxorubicin Hydrochloride	Doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 + Strontium chloride Sr 89 IV on day 1.
Arm II: No Celecoxib	Strontium chloride Sr 89	Doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 + Strontium chloride Sr 89 IV on day 1.

Primary Outcome Measures

Name	Time	Method
Time to prostate-specific antigen progression	Continuous assessment 16 weeks of treatment

Trial Locations

Locations (1)

M.D. Anderson Cancer Center at University of Texas; 🇺🇸 Houston, Texas, United States