Intravenous Estramustine With Taxol in Hormone Refractory Prostate Adenocarcinoma
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038168
First received: May 29, 2002
Last updated: July 31, 2012
Last verified: July 2012
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Purpose
Phase I: The goal of this clinical research study is to find the highest dose of estramustine phosphate administered intravenously in combination with a fixed dose of Taxol (paclitaxel) that can be given safely to participants with prostate cancer who have failed to further benefit from hormone treatment.
Phase II: The goal of this clinical research study is to find out if the combination of the drugs estramustine phosphate and paclitaxel will shrink or control prostate cancer that has not responded to hormone treatment. A second goal is to find out if the side effects of these drugs can be reversed. The safety of these drugs will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Estramustine Drug: Taxol |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of Intravenous Estramustine Phosphate Combined With Taxol in Patients With Hormone Refractory Adenocarcinoma of the Prostate |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Response Rate [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
| Enrollment: | 14 |
| Study Start Date: | June 2000 |
| Study Completion Date: | January 2003 |
| Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Estramustine + Taxol |
Drug: Estramustine
Intravenous dose
Other Name: Estramustine phosphate
Drug: Taxol
Intravenous dose
Other Name: Paclitaxel
|
Detailed Description:
To determine the maximum tolerated dose of intravenous estramustine phosphate combined with Taxol.
To estimate the complete and partial response rates to treatments with intravenous estramustine phosphate combined with Taxol in the treatment of hormone-refractory adenocarcinoma of the prostate.
To determine the qualitative and quantitative toxicity of the combination of intravenous estramustine phosphate and Taxol.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with histologic proof of adenocarcinoma of the prostate and must have failed conventional hormonal therapy.
- Patients must have osteoblastic bone metastases. At least one osteoblastic lesion must be documented by plain film. Patients with mixed or osteolytic bone metastases must have a biopsy to exclude histologic variants of prostate cancer or metastasis from another primary (for phase II only).
- Patients must have evidence of progression of disease as demonstrated by 2 consecutive rise in PSA (an absolute change of at least 1 ng/mL) over 4 weeks.
- Patients on flutamide, nilutamide, or bicalutamide should be discontinued from flutamide or nilutamide and bicalutamide for at least 4 weeks and 8 weeks, respectively.
- Patients must have an expected survival of at least three months and a Zubrod performance status of < 2 (Zubrod scale; Appendix B).
- Patients may receive no concurrent chemotherapy or immunotherapy.
- Patients must have castrate serum testosterone levels (< 30 ng/dl). For patients who are medically castrated, lutenizing hormone releasing hormone analog must continue to maintain testicular suppression.
- Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of > 1,500/mm3 and platelet count of > 100,000/mm3; adequate hepatic function defined with a bilirubin of < 1.5 mg% and SGOT (AST) < 2X the upper limits of normal; adequate renal function defined as serum creatinine clearance > 40 cc/min (measured or calculated).
- Patients must be >= 18 years old.
- Patients may have received oral EMP or no more than one cytotoxic therapy.
- Patients must sign a written informed consent form prior to treatment.
Exclusion Criteria:
- Patients with severe intercurrent infection.
- Patients with prior exposure to Taxol.
- Patients whose tumors contain small cell or sarcomatoid elements.
- Patients with evidence of conduction block or active myocardial ischemia on ECG.
- Patients with a history of prior malignancy (except noninvasive cutaneous carcinoma).
- Patients with a history of thromboembolism.
Contacts and Locations More Information
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038168 History of Changes |
| Other Study ID Numbers: | DM98-268 |
| Study First Received: | May 29, 2002 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Prostate Cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Estramustine Paclitaxel |
Hormones Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013