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A Randomized Phase II Trial of Bone-Targeted Therapy Consisting of Strontium-89 and Doxorubicin With or Without Celecoxib in Androgen-Independent Prostate Cancer


Phase 2
N/A
N/A
Not Enrolling
Male
Metastatic Cancer, Prostate Cancer

Thank you

Trial Information

A Randomized Phase II Trial of Bone-Targeted Therapy Consisting of Strontium-89 and Doxorubicin With or Without Celecoxib in Androgen-Independent Prostate Cancer


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.

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to prostate-specific antigen progression

Outcome Time Frame:

Continuous assessment 16 weeks of treatment

Safety Issue:

No

Principal Investigator

Shi-Ming Tu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID02-035

NCT ID:

NCT00080782

Start Date:

February 2002

Completion Date:

January 2005

Related Keywords:

  • Metastatic Cancer
  • Prostate Cancer
  • 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
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Prostatic Neoplasms

Name

Location
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030