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

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT00006114

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: mitoxantrone hydrochloride Drug: vinorelbine tartrate	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine

Study Start Date :

May 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Hopital Saint-Louis	Amiens	France	80054 Cedex 1
2	Hopital Gouin	Clichy	France	92110
3	Hopital Perpetuel Secours	Levallois-Perret	France	92300
4	CHU de la Timone	Marseille	France	13385
5	Hopital Laennec	Paris	France	75007
6	Hopital Saint Antoine	Paris	France	75571
7	Hopital Tenon	Paris	France	75970
8	Polyclinique De Courlancy	Reims	France	F-51100
9	C.H. Senlis	Senlis	France	60309
10	Centre Hospitalier Intercommunal Toulon - La Seyne/Mer	Toulon - Cedex	France	83056