Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

NCT ID: NCT00258284

Last Updated: 2014-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2007-11-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel & Capecitabine

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

Group Type: EXPERIMENTAL

capecitabine

Intervention Type: DRUG

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

docetaxel

Intervention Type: DRUG

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

Interventions

capecitabine

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

docetaxel

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

Other Intervention Names

Xeloda®; Taxotere®

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Ulka Vaishampayan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulka N. Vaishampayan, MD

Role: STUDY_CHAIR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

Other Identifiers

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-D-2615

Identifier Type: -

Identifier Source: secondary_id

WSU-HIC-067903MP4F

Identifier Type: -

Identifier Source: secondary_id

CDR0000445613

Identifier Type: -

Identifier Source: org_study_id