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Trial Information: Protocol Number S0421 (Prostate)

General Information

Protocol Title: Phase III Study of Docetaxel and Atrasentan versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer

Offered At: Providence Cancer Institute

Protocol Number: S0421

Trial Type: Prostate

Background:

The purpose of this study is to compare the effects (good and bad) of the combination of docetaxel and prednisone plus atrasentan against the combination of docetaxel and prednisone plus placebo on prostate cancer to see which is better.

Eligibility Information

Eligible Patients must: 

  • with histologic diagnosis of adenocarcinoma of the prostate which is measurable or non-measurable.
  • Stage Tany, Nany, M1b with evidence of bone metastases on bone scan (no past or current brain mets).
  • The cancer must be deemed unresponsive or refractory to hormone therapy.
  • Patients must have been surgically or medically castrated.
  • Patients may have had prior RT and prior surgery as long as at least 21 days have passed since the completion of treatment.
  • Patients may have had one prior systemic therapy as long as at least 28 days have passed since completion.
  • Patients may not have received prior cytotoxic chemotherapy for metastatic disease, but may have received adjuvant therapy with non-taxane containing regimen if more than 2 years have passed since completion.
  • Patient may take bisphosphonates during the study as long as they were started prior to enrollment.
  • Patients must not have ¡Ý grade 2 symptomatic sensory neuropathy.
  • must have Zubrod PS 0-3 (3 only if 2¡ã to bone metastases).


Ineligibility Information

Patients are ineligible if they: 

  • Patients have taken CYP3A4 inhibiting/inducing drugs within 14 days (6 months for amiodarone) prior to starting Docetaxel

Contact Information

Contact Name: Jaswinder Grewal

Contact Phone: 248-849-5337

Contact E-mail: jgrewal@providence-hospital.org



 

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