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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.
First Received: August 3, 2000   Last Updated: July 23, 2008   History of Changes
Sponsor: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006114
  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 ditartrate
Phase II

Study Type: Interventional
Study Design: 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

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006114

Locations
France
C.H. Senlis
Senlis, France, 60309
Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
Toulon - Cedex, France, 83056
CHU de la Timone
Marseille, France, 13385
Hopital Gouin
Clichy, France, 92110
Hopital Laennec
Paris, France, 75007
Polyclinique De Courlancy
Reims, France, F-51100
Hopital Saint Antoine
Paris, France, 75571
Hopital Saint-Louis
Amiens, France, 80054 Cedex 1
Hopital Tenon
Paris, France, 75970
Hopital Perpetuel Secours
Levallois-Perret, France, 92300
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Jean-Louis Wendling, MD Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068126, FRE-GERCOR-NONA-U98-1, EU-20025
Study First Received: August 3, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006114     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Urogenital Neoplasms
Vinblastine
Antimitotic Agents
Genital Diseases, Male
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Vinorelbine
Sensory System Agents
Therapeutic Uses
Tubulin Modulators
Peripheral Nervous System Agents
Analgesics
Mitoxantrone
Antineoplastic Agents, Phytogenic
Central Nervous System Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009