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Atrasentan and Zometa for Men With Androgen Independent Prostate Cancer Metastatic to Bone: A Randomized Pilot Study


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer, Adenocarcinoma of the Prostate

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Trial Information

Atrasentan and Zometa for Men With Androgen Independent Prostate Cancer Metastatic to Bone: A Randomized Pilot Study


- Patients will be randomized to either receive Atrasentan alone or Atrasentan plus
Zometa.

- Patients receiving Atrasentan alone will receive this drug in pill form once daily for
12 weeks. Patients will have a physical exam, blood work, and a urine sample performed
once every other week during the first four weeks of medication administration. After
those two initial visits, they will return to the clinic once every 4 weeks to have the
same tests repeated. A bone scan and abdominal-pelvic CT Scan will be done every 12
weeks.

- After the patient has been taking Atrasentan for 12 weeks, if the disease has not
progressed, they will begin combination treatment of Atrasentan and Zometa.

- Patients receiving Atrasentan plus Zometa, receive Zometa intravenously and then
immediately start Atrasentan orally once daily as long as they remain on the study.
Patients will return to the clinic twice over the first 4 weeks (once every other week)
to have a physical exam, blood work and urine test performed. After these two initial
visits, they will return to the clinic once every 4 weeks to have the tests repeated
and to receive another treatment of zometa. A bone scan and an abdominal-pelvic CT
Scan will be done once every 12 weeks.

- Patients participation in this study will last as long as the disease does not progress
and they are not experiencing any serious side effects.


Inclusion Criteria:



- Histologically confirmed adenocarcinoma of the prostate

- History of bilateral orchiectomy or current treatment with a GnRH agonist or
antagonist

- Radiographically documented bone metastases

- Disease progression according to criteria from the PSA Working Group

Exclusion Criteria:

- Prior treatment with Atrasentan or Zometa within one year

- Serum creatinine > 2.0mg/dL

- Documented cardiovascular disability status of New York Heart Association Class 2

- Treatment with chemotherapy, radiation, steroids, estrogens, or PC-SPES within 6
weeks

- Treatment with bisphosphonates or radiopharmaceuticals within 12 weeks

- History of Paget's disease, hyperthyroidism, hyperparathyroidism, Cushing's syndrome,
hyperprolactinemia or other disorder associated with metabolic bone disease.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare the effects of Atrasentan monotherapy with combination therapy using Atrasentan and Zometa on bone specific alkaline phosphatase.

Principal Investigator

Matthew Smith, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

01-200

NCT ID:

NCT00181558

Start Date:

December 2001

Completion Date:

December 2006

Related Keywords:

  • Prostate Cancer
  • Adenocarcinoma of the Prostate
  • Prostate Cancer
  • bone metastases
  • Atrasentan
  • Zometa
  • Androgen Independent Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases
  • Neoplasm Metastasis

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617