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Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma Phase II Trials Protocol 4: Vinorelbine

Phase 2
18 Years
85 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma Phase II Trials Protocol 4: Vinorelbine

OBJECTIVES: I. Evaluate the efficacy of vinorelbine in patients with metastatic
hormone-resistant prostate cancer. II. Evaluate the toxicity of vinorelbine in these
patients. III. Evaluate the quality of life of these patients, and correlate quality of life
with PSA response.

OUTLINE: Patients receive a 5-10 minute intravenous infusion of vinorelbine on day 1 and day
8 of a 21-day course. Patients with stabilization of their disease, partial response, or
complete response, receive a maximum of 12 courses of treatment. Patients showing disease
progression or severe toxic side effects discontinue treatment. Quality of life and pain are
assessed prior to treatment, at days 1 and 8 of each course, and at end of the treatment.
Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 14-40 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic stage IV
prostate cancer Proven hormonal resistance Measurable or evaluable disease PSA at least 3
times upper limit of normal No leptomeningeal or brain metastases

PATIENT CHARACTERISTICS: Age: 18 to 85 Performance status: WHO 0-2 Life expectancy:
Greater than 12 weeks Hematopoietic: WBC at least 3500/mm3 OR Granulocyte count at least
2000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin
no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN
Renal: Creatinine no greater than 1.5 times ULN Other: No acute severe infections No other
neoplastic diseases except curatively treated basal cell or squamous cell carcinoma of the
skin, or relapse free for more than 5 years after curative treatment of a neoplasm

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
cytostatic chemotherapy Endocrine therapy: At least 1 month since antiandrogens Prior
hormonal therapy required Radiotherapy: No radiotherapy within the past 4 weeks No
radiotherapy to the lesions used to evaluate activity of the study drug Surgery: Prior
orchiectomy allowed Other: No other investigational drugs during the last month No prior
therapy with cytostatic agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Rudolf Morant, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kantonsspital St. Gallen


Switzerland: Swissmedic

Study ID:

SAKK 08/97



Start Date:

October 1997

Completion Date:

September 1999

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms