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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006114
First Posted: January 27, 2003
Last Update Posted: March 1, 2011
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.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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:

OBJECTIVES:

  • 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.

  Eligibility

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.


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

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

  • 18 to 80

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine less than 2 times ULN

Cardiovascular:

  • Adequate cardiac function

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

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

Radiotherapy:

  • At least 8 weeks since prior extensive radiotherapy

Surgery:

  • See Disease Characteristics
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00006114


Locations
France
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
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
Study Chair: Jean-Louis Wendling, MD Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
  More Information

ClinicalTrials.gov Identifier: NCT00006114     History of Changes
Other Study ID Numbers: CDR0000068126
FRE-GERCOR-NONA-U98-1
EU-20025
First Submitted: August 3, 2000
First Posted: January 27, 2003
Last Update Posted: March 1, 2011
Last Verified: September 2000

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Vinorelbine
Mitoxantrone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action