Try our beta test site

Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: December 18, 2013
Last verified: March 2005

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 Intervention Phase
Prostate Cancer
Drug: docetaxel
Drug: estramustine phosphate sodium
Drug: mitoxantrone hydrochloride
Drug: prednisone
Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 12
Study Start Date: August 1998
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003633

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
Study Chair: Daniel P. Petrylak, MD Herbert Irving Comprehensive Cancer Center
  More Information Identifier: NCT00003633     History of Changes
Other Study ID Numbers: CDR0000066717
Study First Received: November 1, 1999
Last Updated: December 18, 2013

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
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
Antineoplastic Agents, Alkylating
Alkylating Agents
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on March 28, 2017