Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Docetaxel

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