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Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma - Phase II Trials - Protocol 5: Capecitabine

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 5: Capecitabine

OBJECTIVES: I. Determine the efficacy of capecitabine in terms of PSA response, PSA response
duration, and time to PSA progression in patients with metastatic hormone refractory
prostate cancer. II. Evaluate the toxicity of this treatment in these patients. III.
Evaluate the correlation between PSA response and quality of life in these patients.

OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days
1-14. Treatment continues every 21 days for up to 8 courses in the absence of disease
progression or unacceptable toxicity. Quality of life is assessed on days 1 and 8 of the
first course of treatment, on day 1 of each course thereafter, and at treatment failure.
Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic hormone
refractory prostate cancer Disease progression after orchiectomy or during hormonal
therapy Measurable or evaluable disease At least 2 consecutive increases in PSA At least 1
week between reference value and first increase OR Third value must be higher than second
if second value is less than reference value PSA at least 5 ng/mL No leptomeningeal or
brain metastases

PATIENT CHARACTERISTICS: Age: 18 to 85 Performance status: WHO 0-2 Life expectancy: Not
specified Hematopoietic: WBC at least 3,500/mm3 OR Granulocyte count at least 2,000/mm3
Hemoglobin at least 9.0 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 other prior malignancies in past
5 years except curatively treated basal cell or squamous cell carcinoma of the skin No
other significant disease that would preclude study No concurrent active severe infections

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior gene therapy and antibody therapy
allowed Chemotherapy: No prior cytostatic chemotherapy, including estramustine Endocrine
therapy: See Disease Characteristics At least 1 month since prior antiandrogen therapy
(e.g., flutamide or bicalutamide) without tumor response OR Concurrent antiandrogen
therapy allowed if clinically unacceptable to discontinue use If disease progressed while
receiving hormonal agents (e.g., goserelin, leuprolide, diethylstilbestrol), therapy must
continue during study Radiotherapy: At least 4 weeks since prior radiotherapy No prior
radiotherapy to lesions to be evaluated No concurrent radiotherapy to more than one area
Surgery: See Disease Characteristics Other: Prior noncytostatic therapy allowed At least 1
month since prior investigational drugs

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 08/00



Start Date:

March 2000

Completion Date:

June 2001

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms