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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
capecitabine
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Spitalzentrum Biel
  • Kantonsspital - Saint Gallen

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
June 24, 2019
Sponsor
Swiss Group for Clinical Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00006023
Brief Title
Capecitabine in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title
Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma - Phase II Trials - Protocol 5: Capecitabine
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
June 2001 (Actual)
Study Completion Date
June 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf Morant, MD
Organizational Affiliation
Cantonal Hospital of St. Gallen
Official's Role
Study Chair
Facility Information:
Facility Name
Spitalzentrum Biel
City
Biel
ZIP/Postal Code
CH-2500
Country
Switzerland
Facility Name
Kantonsspital - Saint Gallen
City
Saint Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
15054447
Citation
Morant R, Bernhard J, Dietrich D, Gillessen S, Bonomo M, Borner M, Bauer J, Cerny T, Rochlitz C, Wernli M, Gschwend A, Hanselmann S, Hering F, Schmid HP. Capecitabine in hormone-resistant metastatic prostatic carcinoma - a phase II trial. Br J Cancer. 2004 Apr 5;90(7):1312-7. doi: 10.1038/sj.bjc.6601673.
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Capecitabine in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

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