Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of estramustine, docetaxel, and carboplatin in treating patients who have prostate cancer that has not responded to hormonal therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: carboplatin Drug: docetaxel Drug: estramustine phosphate sodium |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Estramustine, Taxotere and Carboplatin (ETP) in Patients With Horomone Refractory Prostate Cancer |
| Study Start Date: | March 1999 |
OBJECTIVES:
- Determine the maximum tolerated dose of weekly docetaxel when combined with carboplatin and estramustine in patients with hormone refractory prostate cancer.
- Determine the safety and efficacy of this regimen in this patient population.
OUTLINE: This is a dose escalation study of docetaxel.
Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 2 of weeks 1-3. Patients also receive carboplatin IV over 1 hour on day 2 of week 1 only. Treatment continues every 28 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 12 months.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
Disease progression following androgen ablation therapy (hormonal or surgical) by either:
- Increase in the product of bidimensional diameters of 1 or more radiographically documented sites of measurable disease OR
Two consecutive increases in PSA documented over a previous reference value
- First increase in PSA should occur a minimum of 1 week from the reference value and be confirmed
- First PSA value is less than the previous value, then patient is eligible provided next PSA is greater than the second PSA
- Testosterone levels documented in the castrate range (i.e., less than 30 ng/mL)
PATIENT CHARACTERISTICS:
Age:
- 18 to 85
Performance status:
- CALGB 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin normal
- SGOT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase normal OR
- Alkaline phosphatase no greater than 4 times ULN if SGOT normal OR
- SGOT no greater than 1.5 times ULN and alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No myocardial infarction within past year
- No significant change in anginal pattern within past 6 months
- No New York Heart Association class II-IV heart disease
- No deep venous thrombosis within past year
Other:
- No significant peripheral neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior chemotherapy allowed except taxanes or platinum derivatives
Endocrine therapy:
- See Disease Characteristics
- At least 4 weeks since prior antiandrogens
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Study Chair: | William Oh, MD | Dana-Farber Cancer Institute |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00005627 History of Changes |
| Other Study ID Numbers: | CDR0000067775, DFCI-98238, RP-DFCI-98238, NCI-G00-1779 |
| Study First Received: | May 2, 2000 |
| Last Updated: | July 31, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the prostate recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Estramustine Docetaxel Carboplatin |
Sodium phosphate Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Cathartics Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 16, 2013