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

NCT ID: NCT00006114

Last Updated: 2011-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-05-31

Brief Summary

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.

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.

Conditions

Prostate Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

mitoxantrone hydrochloride

Intervention Type: DRUG

vinorelbine tartrate

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role: lead

Principal Investigators

Jean-Louis Wendling, MD

Role: STUDY_CHAIR

Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer

Locations

Hopital Saint-Louis

Amiens, , France

Hopital Gouin

Clichy, , France

Hopital Perpetuel Secours

Levallois-Perret, , France

CHU de la Timone

Marseille, , France

Hopital Laennec

Paris, , France

Hopital Saint Antoine

Paris, , France

Hopital Tenon

Paris, , France

Polyclinique De Courlancy

Reims, , France

C.H. Senlis

Senlis, , France

Centre Hospitalier Intercommunal Toulon - La Seyne/Mer

Toulon, , France

Countries

France

Other Identifiers

FRE-GERCOR-NONA-U98-1

Identifier Type: -

Identifier Source: secondary_id

EU-20025

Identifier Type: -

Identifier Source: secondary_id

CDR0000068126

Identifier Type: -

Identifier Source: org_study_id