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Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
capecitabine
docetaxel
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Metastatic disease Androgen-independent disease Progressive disease, as documented by ≥ 1 of the following criteria: Rising prostate-specific antigen (PSA) despite androgen deprivation therapy and anti-androgen withdrawal Demonstrates a rising PSA trend with 2 successive elevations ≥ 1 week apart Measurable disease progression Nonmeasurable disease progression, defined as the following: PSA ≥ 5 ng/mL New areas of bone metastases on bone scan Serum testosterone ≤ 0.5 ng/mL (castrate level) Concurrent luteinizing hormone-releasing hormone agonist therapy required for medically castrated patients PATIENT CHARACTERISTICS: Performance status Zubrod 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/ mm^3 Hemoglobin ≥ 8.0 g/dL Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal Transaminases meeting 1 of the following criteria: AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase (AP) normal AP ≤ 4 times ULN if AST and/or ALT normal Renal Creatinine clearance ≥ 50 mL/min OR Creatinine ≤ 2 mg/dL Cardiovascular No congestive heart failure No second- or third-degree heart block No myocardial infarction within the past 3 months Other Fertile patients must use effective contraception during and for 6 months after completion of study treatment No other malignancy within the past 2 years except adequately treated skin cancer or other cancer in complete remission No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 No peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy for metastatic disease Endocrine therapy See Disease Characteristics More than 4 weeks since prior flutamide More than 6 weeks since prior bicalutamide or nilutamide Radiotherapy At least 4 weeks since prior radiotherapy Other At least 28 days since prior investigational drugs for prostate cancer No other concurrent anti-cancer therapy

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel & Capecitabine

Arm Description

Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR

Outcomes

Primary Outcome Measures

Response rate by RECIST criteria after every 2 courses

Secondary Outcome Measures

Toxicity at 30 days after last treatment
Progression-free survival
Time to treatment failure
From date of registration to date of progressive disease, or date patient is taken off study for any other reason.
Overall survival
Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase)

Full Information

First Posted
November 22, 2005
Last Updated
March 5, 2014
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00258284
Brief Title
Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Official Title
Phase II Trial of Capecitabine (Xeloda) and Weekly Docetaxel (Taxotere) in Metastatic Androgen Independent Prostate Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel works in treating patients with metastatic prostate cancer.
Detailed Description
OBJECTIVES: Primary Determine the response rate in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with capecitabine and docetaxel. Secondary Determine the toxicity of this regimen in these patients. Determine the progression-free survival, time to treatment failure, and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR After completion of study treatment, patients are followed periodically for survival. PROJECTED ACCRUAL: A total of 28 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
recurrent prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel & Capecitabine
Arm Type
Experimental
Arm Description
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
Intervention Type
Drug
Intervention Name(s)
capecitabine
Other Intervention Name(s)
Xeloda®
Intervention Description
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
Taxotere®
Intervention Description
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
Primary Outcome Measure Information:
Title
Response rate by RECIST criteria after every 2 courses
Time Frame
at cycle 2 and every other cycle thereafter
Secondary Outcome Measure Information:
Title
Toxicity at 30 days after last treatment
Time Frame
Every week during treatment cycles
Title
Progression-free survival
Time Frame
Every 2 cycles
Title
Time to treatment failure
Description
From date of registration to date of progressive disease, or date patient is taken off study for any other reason.
Time Frame
Every 2 cycles
Title
Overall survival
Time Frame
Every 2 cycles
Title
Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase)
Time Frame
Every week during treatment cycles

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Metastatic disease Androgen-independent disease Progressive disease, as documented by ≥ 1 of the following criteria: Rising prostate-specific antigen (PSA) despite androgen deprivation therapy and anti-androgen withdrawal Demonstrates a rising PSA trend with 2 successive elevations ≥ 1 week apart Measurable disease progression Nonmeasurable disease progression, defined as the following: PSA ≥ 5 ng/mL New areas of bone metastases on bone scan Serum testosterone ≤ 0.5 ng/mL (castrate level) Concurrent luteinizing hormone-releasing hormone agonist therapy required for medically castrated patients PATIENT CHARACTERISTICS: Performance status Zubrod 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/ mm^3 Hemoglobin ≥ 8.0 g/dL Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal Transaminases meeting 1 of the following criteria: AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase (AP) normal AP ≤ 4 times ULN if AST and/or ALT normal Renal Creatinine clearance ≥ 50 mL/min OR Creatinine ≤ 2 mg/dL Cardiovascular No congestive heart failure No second- or third-degree heart block No myocardial infarction within the past 3 months Other Fertile patients must use effective contraception during and for 6 months after completion of study treatment No other malignancy within the past 2 years except adequately treated skin cancer or other cancer in complete remission No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 No peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy for metastatic disease Endocrine therapy See Disease Characteristics More than 4 weeks since prior flutamide More than 6 weeks since prior bicalutamide or nilutamide Radiotherapy At least 4 weeks since prior radiotherapy Other At least 28 days since prior investigational drugs for prostate cancer No other concurrent anti-cancer therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulka N. Vaishampayan, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States

12. IPD Sharing Statement

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Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

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