Intravenous Estramustine With Taxol in Hormone Refractory Prostate Adenocarcinoma - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038168

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Estramustine Drug: Taxol	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I/II Study of Intravenous Estramustine Phosphate Combined With Taxol in Patients With Hormone Refractory Adenocarcinoma of the Prostate

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Paclitaxel Estramustine phosphate sodium Estramustine Estramustine phosphate

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Response Rate [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]

Enrollment:	14
Study Start Date:	June 2000
Study Completion Date:	January 2003
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Estramustine + Taxol	Drug: Estramustine Intravenous dose Other Name: Estramustine phosphate Drug: Taxol Intravenous dose Other Name: Paclitaxel

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.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038168

Locations

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

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Study Chair:

Jeri Kim, M.D.

UT MD Anderson Cancer Center

More Information

No publications provided

Responsible Party:	Jeri Kim, MD / Associate Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038168 History of Changes
Other Study ID Numbers:	DM98-268
Study First Received:	May 29, 2002
Last Updated:	July 7, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Prostate Cancer

Additional relevant MeSH terms:

Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Estramustine
Paclitaxel
Hormones

Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 09, 2012