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Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: Barbara Ann Karmanos Cancer Institute
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00258284
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: capecitabine
Drug: docetaxel
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Docetaxel Capecitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of Capecitabine (Xeloda) and Weekly Docetaxel (Taxotere) in Metastatic Androgen Independent Prostate Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate by RECIST criteria after every 2 courses [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity at 30 days after last treatment [ Designated as safety issue: Yes ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase) weekly during treatment [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: August 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258284

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
United States, North Carolina
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States, 28501
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Ulka N. Vaishampayan, MD Barbara Ann Karmanos Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000445613, WSU-D-2615, WSU-HIC-067903MP4F
Study First Received: November 22, 2005
Last Updated: May 23, 2008
ClinicalTrials.gov Identifier: NCT00258284  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate

Study placed in the following topic categories:
Docetaxel
Capecitabine
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009