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

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Cancer; Prostate Cancer

Intervention: Celecoxib (Drug); Doxorubicin Hydrochloride (Drug); Strontium chloride Sr 89 (Radiation)

Phase: Phase 2

Status: Terminated

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Shi-Ming Tu, MD, Study Chair, Affiliation: M.D. Anderson Cancer Center

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to prostate-specific antigen progression

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

M.D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States
Additional Information

UT MD Anderson Cancer Center Website

Starting date: February 2002
Last updated: July 27, 2012

Page last updated: August 23, 2015

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