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A Multicenter, Open-Label, Phase II Trial of Adjuvant Taxotere in Patients At High Risk of Relapse Following Prostatectomy


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Multicenter, Open-Label, Phase II Trial of Adjuvant Taxotere in Patients At High Risk of Relapse Following Prostatectomy

Inclusion Criteria


INCLUSION CRITERIA:

- patients with prostate cancer who have just undergone prostatectomy,

- high risk of their cancer recurring (High risk is defined as at least a 50 percent
chance the cancer will return within three years after surgery.)

EXCLUSION CRITERIA:

- Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or
any other anticancer therapy.

- Prior radiation therapy

- Patients receiving any concurrent therapy for cancer. This includes alternative
therapies

- Patients requiring concurrent treatment with corticosteroids, with the exception of
inhaled and topical corticosteroids.

- History of a malignancy other than prostate cancer

- Peripheral neuropathy >/= Grade 2

- Psychological, familial, sociological or geographical conditions which do not permit
treatment and/or medical follow-up required to comply with the study protocol

- Patients with a history of hypersensitivity reaction to products containing
Polysorbate 80 (Tween 80).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the preliminary effects of six cycles of adjuvant, weekly Taxotere® (three weeks on/one week off) on the rate of progression-free survival

Principal Investigator

Yasir Nagarwala, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

XRP6976J_2501

NCT ID:

NCT00069888

Start Date:

November 2001

Completion Date:

January 2007

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Sanofi-Aventis USBridgewater, New Jersey  08807