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Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003633
Recruitment Status : Unknown
Verified March 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with advanced prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: docetaxel Drug: estramustine phosphate sodium Drug: mitoxantrone hydrochloride Drug: prednisone Phase 1

Detailed Description:


  • Determine the maximum tolerated doses of docetaxel and mitoxantrone in combination with a fixed dose of estramustine and prednisone, when given to patients with advanced prostate cancer.
  • Characterize the toxicity of this treatment regimen in these patients.

OUTLINE: This is a dose escalation study of mitoxantrone and docetaxel. Patients are stratified into one of two risk groups (good risk group or poor risk group) based on the number of prior chemotherapy regimen(s) and the occurrence and sites(s) of prior radiation.

All patients receive oral prednisone twice daily on days 0-3, oral estramustine three times daily on days 1-5, mitoxantrone IV bolus on day 2, and docetaxel IV over 1 hour on day 2. Courses repeat every 21 days in the absence of unacceptable toxicity and disease progression. Patients with stable disease may go off treatment after 6 courses.

Dose escalation proceeds independently for each risk group. Cohorts of 3 patients are entered into each risk group. If 1 of 3 patients at a dose level experiences dose limiting toxicity (DLT), then 3 additional patients are accrued into this level. If 2 of 6 patients at a dose level experience DLT, then dose escalation stops and the maximum tolerated dose (MTD) is defined at the previous dose level. At least 6 patients must be treated at the MTD.

Patients are followed every 3 months until death.

PROJECTED ACCRUAL: At least 12 patients (6 in each risk group) will be accrued into this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Primary Purpose: Treatment
Official Title: Treatment of Prostate Cancer by Induction of Alternate Cell Death Pathways: A Phase I Trial of Docetaxel, Estramustine, Mitoxantrone and Prednisone
Study Start Date : August 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate
  • Failure of complete androgen ablation (orchiectomy or LHRH and antiandrogen therapy) as manifested by at least 1 of the following criteria:

    • Rise in serum PSA greater than 50% of nadir confirmed on 2 measurements 1 week apart
    • Appearance of new lesions on bone scan
    • Appearance of new soft-tissue lesions
  • Measurable or evaluable disease
  • No brain or leptomeningeal involvement



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Greater than 3 months


  • WBC at least 3,500/mm3
  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin no greater than upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 5 times ULN
  • SGOT and SGPT no greater than 2 times ULN


  • Creatinine no greater than 2 times ULN


  • No history of coagulopathy
  • No myocardial infarction in the last 6 months
  • No history of cardiovascular accident
  • No history of congestive heart failure


  • No symptomatic peripheral neuropathy greater than grade 1
  • No history of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures


  • No history of pulmonary embolus


  • Testosterone no greater than 3.5 nmol/L
  • No contraindications to glucocorticoid therapy such as uncontrolled diabetes mellitus or active peptic ulcer disease
  • No active infection
  • No other serious illness or medical condition
  • No other concurrent or prior malignancy in the past 5 years except previously excised or curatively irradiated nonmelanoma skin cancer


Biologic therapy:

  • Not specified


  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior hormonal therapy (including nonsteroidal antiandrogens, but not LHRH agonists)


  • No prior radiotherapy to greater than 30% of bone marrow
  • At least 6 weeks since isotope therapy
  • At least 4 weeks since prior radiotherapy


  • See Disease Characteristics


  • At least 4 weeks since prior investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003633

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United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
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Study Chair: Daniel P. Petrylak, MD Herbert Irving Comprehensive Cancer Center
Layout table for additonal information Identifier: NCT00003633    
Other Study ID Numbers: CDR0000066717
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: March 2005
Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents