Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00258284
First received: November 22, 2005
Last updated: March 5, 2014
Last verified: March 2014
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Capecitabine (Xeloda) and Weekly Docetaxel (Taxotere) in Metastatic Androgen Independent Prostate Carcinoma

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Response rate by RECIST criteria after every 2 courses [ Time Frame: at cycle 2 and every other cycle thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity at 30 days after last treatment [ Time Frame: Every week during treatment cycles ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
    From date of registration to date of progressive disease, or date patient is taken off study for any other reason.

  • Overall survival [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
  • Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase) [ Time Frame: Every week during treatment cycles ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: August 2003
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: 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
Other Name: Xeloda®
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
Other Name: Taxotere®

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Ulka N. Vaishampayan, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Ulka Vaishampayan, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00258284     History of Changes
Other Study ID Numbers: CDR0000445613, P30CA022453, WSU-D-2615, WSU-HIC-067903MP4F
Study First Received: November 22, 2005
Last Updated: March 5, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:
recurrent prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014