Trial | NCT00006114  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    None
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.
Study Started
May 31
1999
Last Update
Mar 01
2011
Estimate

Drug mitoxantrone hydrochloride

Drug vinorelbine tartrate

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
No Results Posted