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Intravenous Estramustine With Taxol in Hormone Refractory Prostate Adenocarcinoma

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Estramustine
Taxol
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Estramustine + Taxol

Arm Description

Outcomes

Primary Outcome Measures

Response Rate

Secondary Outcome Measures

Full Information

First Posted
May 29, 2002
Last Updated
July 31, 2012
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00038168
Brief Title
Intravenous Estramustine With Taxol in Hormone Refractory Prostate Adenocarcinoma
Official Title
Phase I/II Study of Intravenous Estramustine Phosphate Combined With Taxol in Patients With Hormone Refractory Adenocarcinoma of the Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Estramustine + Taxol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Estramustine
Other Intervention Name(s)
Estramustine phosphate
Intervention Description
Intravenous dose
Intervention Type
Drug
Intervention Name(s)
Taxol
Other Intervention Name(s)
Paclitaxel
Intervention Description
Intravenous dose
Primary Outcome Measure Information:
Title
Response Rate
Time Frame
Study Completion

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeri Kim, M.D.
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Intravenous Estramustine With Taxol in Hormone Refractory Prostate Adenocarcinoma

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