Intravenous Estramustine With Taxol in Hormone Refractory Prostate Adenocarcinoma

July 31, 2012 updated by: M.D. Anderson Cancer Center

Phase I/II Study of Intravenous Estramustine Phosphate Combined With Taxol in Patients With Hormone Refractory Adenocarcinoma of the Prostate

Phase I: The goal of this clinical research study is to find the highest dose of estramustine phosphate administered intravenously in combination with a fixed dose of Taxol (paclitaxel) that can be given safely to participants with prostate cancer who have failed to further benefit from hormone treatment.

Phase II: The goal of this clinical research study is to find out if the combination of the drugs estramustine phosphate and paclitaxel will shrink or control prostate cancer that has not responded to hormone treatment. A second goal is to find out if the side effects of these drugs can be reversed. The safety of these drugs will also be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To determine the maximum tolerated dose of intravenous estramustine phosphate combined with Taxol.

To estimate the complete and partial response rates to treatments with intravenous estramustine phosphate combined with Taxol in the treatment of hormone-refractory adenocarcinoma of the prostate.

To determine the qualitative and quantitative toxicity of the combination of intravenous estramustine phosphate and Taxol.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients with histologic proof of adenocarcinoma of the prostate and must have failed conventional hormonal therapy.
  • Patients must have osteoblastic bone metastases. At least one osteoblastic lesion must be documented by plain film. Patients with mixed or osteolytic bone metastases must have a biopsy to exclude histologic variants of prostate cancer or metastasis from another primary (for phase II only).
  • Patients must have evidence of progression of disease as demonstrated by 2 consecutive rise in PSA (an absolute change of at least 1 ng/mL) over 4 weeks.
  • Patients on flutamide, nilutamide, or bicalutamide should be discontinued from flutamide or nilutamide and bicalutamide for at least 4 weeks and 8 weeks, respectively.
  • Patients must have an expected survival of at least three months and a Zubrod performance status of < 2 (Zubrod scale; Appendix B).
  • Patients may receive no concurrent chemotherapy or immunotherapy.
  • Patients must have castrate serum testosterone levels (< 30 ng/dl). For patients who are medically castrated, lutenizing hormone releasing hormone analog must continue to maintain testicular suppression.
  • Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of > 1,500/mm3 and platelet count of > 100,000/mm3; adequate hepatic function defined with a bilirubin of < 1.5 mg% and SGOT (AST) < 2X the upper limits of normal; adequate renal function defined as serum creatinine clearance > 40 cc/min (measured or calculated).
  • Patients must be >= 18 years old.
  • Patients may have received oral EMP or no more than one cytotoxic therapy.
  • Patients must sign a written informed consent form prior to treatment.

Exclusion Criteria:

  • Patients with severe intercurrent infection.
  • Patients with prior exposure to Taxol.
  • Patients whose tumors contain small cell or sarcomatoid elements.
  • Patients with evidence of conduction block or active myocardial ischemia on ECG.
  • Patients with a history of prior malignancy (except noninvasive cutaneous carcinoma).
  • Patients with a history of thromboembolism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Estramustine + Taxol
Drug: Estramustine
Intravenous dose
Other Names:
  • Estramustine phosphate
Drug: Taxol
Intravenous dose
Other Names:
  • Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response Rate
Time Frame: Study Completion
Study Completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Study Chair: Jeri Kim, M.D., UT MD Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Primary Completion (ACTUAL)

January 1, 2003

Study Completion (ACTUAL)

January 1, 2003

Study Registration Dates

First Submitted

May 29, 2002

First Submitted That Met QC Criteria

May 29, 2002

First Posted (ESTIMATE)

May 30, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM98-268

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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