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Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
This study is ongoing, but not recruiting participants.
Study NCT00006114   Information provided by National Cancer Institute (NCI)
First Received: August 3, 2000   Last Updated: July 23, 2008   History of Changes

August 3, 2000
July 23, 2008
May 1999
 
 
 
Complete list of historical versions of study NCT00006114 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine

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.

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.

Phase II
Interventional
Treatment
Prostate Cancer
  • Drug: mitoxantrone hydrochloride
  • Drug: vinorelbine ditartrate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Male
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00006114
 
CDR0000068126, FRE-GERCOR-NONA-U98-1, EU-20025
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
 
Study Chair: Jean-Louis Wendling, MD Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
National Cancer Institute (NCI)
September 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP