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Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

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 September 2000 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 3, 2000
Last updated: February 26, 2011
Last verified: September 2000

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: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Condition Intervention Phase
Prostate Cancer Drug: mitoxantrone hydrochloride Drug: vinorelbine tartrate Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine

Resource links provided by NLM:

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

Study Start Date: May 1999
Detailed Description:


  • Determine the efficacy of the combination of mitoxantrone and vinorelbine in terms of response rate, progression free survival, overall survival, and quality of life in patients with metastatic hormone refractory adenocarcinoma of the prostate.
  • Determine the toxicities of this treatment regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 8. Treatment repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed prior to treatment, prior to each course, and then at 2 months after study completion.

Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed stage IV hormone refractory adenocarcinoma of the prostate
  • Progressive disease despite hormonal therapy or orchiectomy
  • No brain metastases



  • 18 to 80

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months


  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 9 g/dL


  • Alkaline phosphatase no greater than 2 times upper limit of normal (ULN) (unless bone metastasis)
  • Bilirubin less than 2 times ULN


  • Creatinine less than 2 times ULN


  • Adequate cardiac function


  • No other prior malignancy except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • Prior corticosteroids allowed if started at least 8 weeks prior to study


  • At least 8 weeks since prior extensive radiotherapy


  • See Disease Characteristics
  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: NCT00006114

Hopital Saint-Louis
Amiens, France, 80054 Cedex 1
Hopital Gouin
Clichy, France, 92110
Hopital Perpetuel Secours
Levallois-Perret, France, 92300
CHU de la Timone
Marseille, France, 13385
Hopital Laennec
Paris, France, 75007
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Polyclinique De Courlancy
Reims, France, F-51100
C.H. Senlis
Senlis, France, 60309
Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
Toulon - Cedex, France, 83056
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Study Chair: Jean-Louis Wendling, MD Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
  More Information Identifier: NCT00006114     History of Changes
Other Study ID Numbers: CDR0000068126
Study First Received: August 3, 2000
Last Updated: February 26, 2011

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
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017