Intravenous Estramustine With Taxol in Hormone Refractory Prostate Adenocarcinoma

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: Prostate Cancer
• Intervention / Treatment: Drug: Estramustine; Drug: Taxol

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Study Completion

Collaborators and Investigators

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

Study record dates

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: Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Phytogenic; Paclitaxel; Estramustine
• Other Study ID Numbers: DM98-268