Estramustine, Etoposide and Paclitaxel Treatment for Hormonally Responsive Adenocarcinoma of the Prostate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00151060
First received: September 6, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted

September 6, 2005
September 6, 2005
December 1998
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  • Estimate the time to treatment failure in patients treated with combined androgen blockade and 4 cycles of estramustine, etoposide and paclitaxel.
  • Determine the overall survival in patients treated with combined androgen blockade and 4 cycles of estramustine, etoposide and paclitaxel.
  • To evaluate the type, frequency and severity of toxicity in this patient population.
Same as current
No Changes Posted
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Estramustine, Etoposide and Paclitaxel Treatment for Hormonally Responsive Adenocarcinoma of the Prostate
Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Patients With Hormonally Responsive Adenocarcinoma of the Prostate

Hormonal therapy is the standard treatment for prostate cancer which has spread to other areas of the body. Despite the high initial response rates to hormonal therapy, the vast majority of men will develop cancer which is no longer responsive to hormone deprivation. The average time for hormonal therapy to be effective is about 18 months. Chemotherapy combinations which can treat the disease when it no longer responds to hormonal therapy have been developed, but these treatments are not curative. One of these combinations is estramustine, etoposide and paclitaxel. In men with far advanced disease, 60% will have a decrease in their PSA or shrinkage of tumors after treatment with this chemotherapy. Despite this, these men have all developed further disease progression requiring additional treatment. One possible way to make chemotherapy more effective is to give it when the number of tumor cells is smallest, and the number of cells to be killed is at a low level. One situation in which this is true is when a man has responded to hormonal therapy any tumors are at their smallest size. This study will test whether the addition of chemotherapy at that time will prolong the time until the cancer becomes unresponsive to hormonal therapy.

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Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: Oral Estramustine, Oral Etoposide, Intravenous Paclitaxel
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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
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All patients must have a histologic diagnosis of adenocarcinoma of the prostate with evidence of metastases on bone or CT scan. Patients with regional metastases to pelvic lymph nodes (D1 disease) as their only site of metastases will be excluded from this study.

Patients on androgen suppression therapy at the time of registration must have received less than seven months of therapy (excluding any neoadjuvant hormonal therapy) and must have a decreasing or stable PSA level.

Patients may not be undergoing concurrent chemotherapy, biologic therapy, or radiation therapy. Prior to radiation therapy must have completed more than 4 weeks prior to registration.

Patients may not have received prior cytotoxic chemotherapy.

Patients may not have evidence of brain metastases or untreated spinal cord compression.

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00151060
UMCC 9815
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University of Michigan
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Principal Investigator: David C. Smith, MD The University of Michigan Comprehensive Cancer Center
University of Michigan
August 2005

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