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Gemcitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: Case Comprehensive Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00276549
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine 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 gemcitabine together with docetaxel works in treating patients with metastatic prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Drug: gemcitabine hydrochloride
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Docetaxel Gemcitabine hydrochloride Gemcitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of Gemcitabine And Docetaxel In Androgen-Independent Metastatic Prostate Cancer

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

Primary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: October 2005
Detailed Description:

OBJECTIVES:

  • Determine the objective response rate and toxicity in patients with androgen-independent metastatic prostate cancer treated with gemcitabine hydrochloride and docetaxel.

OUTLINE: This is an open-label study.

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 followed by docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for at least 5 years.

PROJECTED ACCRUAL: A total of 36 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

    • Androgen-independent metastatic prostate cancer with evidence of clinical, radiographic, or biochemical progression in the setting of castrate levels of testosterone (< 50 mg/dL)

      • No androgen-independent prostate cancer with a rising prostate-specific antigen (PSA) without clinical or radiographic evidence of metastases
    • Clinical or radiographic evidence of metastatic disease with a rising PSA measured 2 times at ≥ 1 week interval allowed
  • Antiandrogen therapy must have been stopped at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to study entry with evidence of either a rising PSA (from baseline) measured twice at least 2 weeks apart or radiographic evidence of disease progression
  • Testicular androgen suppression (< 50 mg/dL) must be maintained with either luteinizing-hormone releasing-hormone (LHRH) therapy or bilateral orchiectomy
  • No clinical evidence of CNS metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 mg/dL
  • AST and ALT ≤ 2 times normal
  • Creatinine < 2 mg/dL
  • No history of severe uncontrolled congestive heart failure (CHF), ventricular dysrhythmias, or severe cardiovascular disease (American Heart Association class III or IV)
  • Disease-free of prior malignancies for ≥ 5 years, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or low-grade, low-stage bladder cancer
  • No active infection or parenteral antibiotics within 7 days of study entry
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No radiation therapy within 4 weeks prior to study entry
  • No filgrastim (G-CSF) within 24 hours before or after study therapy
  • No prior systemic chemotherapy for metastatic disease

    • Neoadjuvant or adjuvant non-taxane chemotherapy more than 1 year prior to study entry allowed
  • No concurrent local radiotherapy for control of pain or life-threatening situations
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276549

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Robert Dreicer, MD, FACP The Cleveland Clinic
  More Information

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

Study ID Numbers: CDR0000446814, CASE-CCF-7143
Study First Received: January 12, 2006
Last Updated: May 23, 2008
ClinicalTrials.gov Identifier: NCT00276549  
Health Authority: United States: Federal Government

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

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

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009