Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00104715
First received: March 3, 2005
Last updated: November 6, 2010
Last verified: April 2008

March 3, 2005
November 6, 2010
October 2004
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  • Overall survival at 36 months [ Designated as safety issue: No ]
  • Progression-free survival (biological progression and/or clinical progression) at 24 months [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Treatment costs [ Designated as safety issue: No ]
  • Toxicity and tolerance [ Designated as safety issue: Yes ]
  • Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00104715 on ClinicalTrials.gov Archive Site
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Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer
Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer.

OBJECTIVES:

  • Compare 36-month overall survival of patients with metastatic prostate adenocarcinoma treated with hormonal therapy and docetaxel vs hormonal therapy alone.
  • Compare 24-month progression-free survival (biological progression and/or clinical progression) in patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.
  • Compare costs of these regimens for these patients.
  • Compare the tolerability of these regimens in these patients.
  • Compare the toxicity profile of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive hormonal therapy comprising 1 of the following: goserelin alone OR goserelin and antiandrogen therapy OR surgical castration. Hormonal therapy continues until the development of hormone resistance. Within 2 months after initiation of hormonal therapy, patients receive docetaxel IV every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive hormonal therapy as in arm I. Quality of life is assessed.

PROJECTED ACCRUAL: A total of 378 patients will be accrued for this study.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Prostate Cancer
  • Drug: antiandrogen therapy
  • Drug: docetaxel
  • Drug: goserelin acetate
  • Procedure: orchiectomy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
378
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DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate adenocarcinoma

    • Metastatic disease
  • Measurable or evaluable disease
  • No brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • WBC ≥ 2,000/mm^3
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) (2.5 times normal if hepatic metastases are present)
  • AST and ALT ≤ 1.5 times ULN (2.5 times normal if hepatic metastases are present)

Renal

  • Creatinine ≤ 150 μmol/L

Cardiovascular

  • No symptomatic coronary disease
  • No congenital cardiac insufficiency
  • No New York Heart Association class III or IV cardiovascular disease
  • No other severe cardiovascular disease

Other

  • No severe peripheral neuropathy
  • No active infection
  • No other malignancy within the past 5 years except basal cell skin cancer
  • No familial, social, geographical, or psychological situation that would preclude study compliance and follow-up
  • No other serious disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for metastatic prostate cancer
  • Prior chemotherapy allowed provided all of the following are true:

    • Chemotherapy was completed > 1 year ago
    • Prostate-specific antigen level has remained stable
    • No development of metastases within 1 year after completion of chemotherapy

Endocrine therapy

  • Prior hormonal therapy within the past 2 months allowed for metastatic prostate cancer

Radiotherapy

  • More than 4 weeks since prior radiotherapy to metastatic sites

Surgery

  • No prior surgical castration

Other

  • No other concurrent investigational drugs
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00104715
CDR0000416096, FRE-FNCLCC-GETUG-15/0403, EU-20505
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UNICANCER
Not Provided
Study Chair: Gwenaelle Gravis, MD Institut Paoli-Calmettes
National Cancer Institute (NCI)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP