Know Cancer

forgot password

Phase I/II Study of Intravenous Estramustine Phosphate Combined With Taxol in Patients With Hormone Refractory Adenocarcinoma of the Prostate

Phase 1/Phase 2
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Phase I/II Study of Intravenous Estramustine Phosphate Combined With Taxol in Patients With Hormone Refractory Adenocarcinoma of the Prostate

To determine the maximum tolerated dose of intravenous estramustine phosphate combined with

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.

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,

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Response Rate

Outcome Time Frame:

Study Completion

Safety Issue:


Principal Investigator

Jeri Kim, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2000

Completion Date:

January 2003

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



MD Anderson Cancer Center Houston, Texas  77030-4096