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Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Patients With Hormonally Responsive Adenocarcinoma of the Prostate


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Patients With Hormonally Responsive Adenocarcinoma of the Prostate

Inclusion Criteria


All patients must have a histologic diagnosis of adenocarcinoma of the prostate with
evidence of metastases on bone or CT scan. Patients with regional metastases to pelvic
lymph nodes (D1 disease) as their only site of metastases will be excluded from this
study.

Patients on androgen suppression therapy at the time of registration must have received
less than seven months of therapy (excluding any neoadjuvant hormonal therapy) and must
have a decreasing or stable PSA level.

Patients may not be undergoing concurrent chemotherapy, biologic therapy, or radiation
therapy. Prior to radiation therapy must have completed more than 4 weeks prior to
registration.

Patients may not have received prior cytotoxic chemotherapy.

Patients may not have evidence of brain metastases or untreated spinal cord compression.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Estimate the time to treatment failure in patients treated with combined androgen blockade and 4 cycles of estramustine, etoposide and paclitaxel.

Principal Investigator

David C. Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Michigan Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UMCC 9815

NCT ID:

NCT00151060

Start Date:

December 1998

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

The University of Michigan Comprehensive CancerAnn Arbor, Michigan