Estramustine, Docetaxel and Zoledronate Treatment in Hormone-Refractory Adenocarcinoma of the Prostate

University of Michigan Rogel Cancer Center

Status and phase: Completed; Phase 2

Conditions: Hormone-Refractory Prostate Cancer

Treatments: Drug: Zoledronic acid; Drug: Estramustine; Drug: Docetaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00151073

UMCC 2001-051

Details and patient eligibility

About

Purpose: The aim of this clinical trail is to evaluate the effectiveness of Zoledronate (Zometa) combined with Estramustine and Docetaxel (Taxotere) in the treatment of patients with hormone-refractory prostate cancer.

Full description

Hormone refractory prostate cancer refers to advanced disease in which the patient no longer responds to conventional hormonal treatment. When hormone therapy is no longer successful, chemotherapy is a treatment option. However, current single-agent treatment has shown to have limited benefit. In this clinical trail, investigators are evaluating the effectiveness of Zoledronate(Zometa) combined with Estramustine and Docetaxel (Taxotere) in the treatment of patients with hormone refractory prostate cancer. Zometa is a bisphosphonate, and may reduce or delay skeletal complications caused by bone metastases. Estramustine and Taxotere are chemotherapy drugs that have shown activity in hormone refractory prostate cancer. Eligible patients will be randomized to receive Estramustine and Docetaxel (Taxotere) in combination with Zometa or Zometa given alone.

Enrollment: 28 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

All patients must have a histologic diagnosis of hormone-refractory adenocarcinoma of the prostate, and hormone refractory disease must be demonstrated by the appearance of new lesions on bone or CT scan and/or a rising PSA value. (No evidence of brain metastasis or untreated spinal cord compression.)

Patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate a rising PSA 4 weeks after withdrawal from flutamide and 6 weeks after withdrawal from bicalutamide.

Patient must not be undergoing current chemotherapy, biologic therapy, other investigational or alternative anti-cancer directed therapy or radiation therapy.

Prior radiation therapy must have completed more than 4 weeks prior to registration.

Patients may not have received prior taxane-based cytotoxic chemotherapy for hormone refractory disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Zoledronate Alone

Experimental group

Description:

Zoledronate is given alone for the first cycle. All subsequent cycles consist of Docetaxel (70mg/m\^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2.

Treatment:

Drug: Estramustine

Drug: Docetaxel

Drug: Zoledronic acid

Docetaxel and Estramustine

Experimental group

Description:

Docetaxel and Estramustine are given for the first cycle of therapy. All subsequent cycles consist of Docetaxel (70mg/m\^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2.

Treatment:

Drug: Estramustine

Drug: Docetaxel

Drug: Zoledronic acid