Paclitaxel, Topotecan, and Estramustine in Treating Patients With Metastatic Hormone-Refractory Prostate Cancer

This study has been withdrawn prior to enrollment.
(Study was never activated at Fox Chase Cancer Center.)
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00084565
First received: June 10, 2004
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel, topotecan, and estramustine together works in treating patients with metastatic hormone therapy-refractory prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: estramustine phosphate sodium
Drug: paclitaxel
Drug: topotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of the Activity of Weekly Paclitaxel, Topotecan Plus Oral Estramustine Phosphate in Metastatic Hormone-Refractory Prostate Carcinoma

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Enrollment: 0
Study Start Date: November 2003
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel, topotecan, and estramustine.
  • Determine the progression-free and overall survival of patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.

Secondary

  • Determine the frequency and number of circulating tumor cells in patients before and after treatment with this regimen and at disease progression.
  • Determine the microtubule morphology, β-tubulin isotype pattern, apoptotic markers, and metaphase chromosome alignment in circulating tumor cells in patients before and after treatment with this regimen and at disease progression.

OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15; topotecan IV over 30 minutes on days 2, 9, and 16; and oral estramustine twice daily on days 1 and 2 of course 1 and on days 0-2, 7-9, and 14-16 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 18-38 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate gland

    • Progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver or lung metastases)
    • Radiologic evidence of hydronephrosis alone dose not constitute metastatic disease
  • Failed prior primary hormonal therapy (e.g., estrogen therapy, luteinizing hormone-releasing hormone blocker and flutamide) or bilateral orchiectomy

    • Patients previously treated with flutamide or bicalutamide must have evidence of disease progression i.e., increasing Prostate-Specific Antigen (PSA)
  • PSA level ≥ 10 ng/mL if bone metastases only are present (i.e., lacking measurable soft tissue disease)
  • No elevated serum acid phosphatase or PSA level as the only evidence of disease
  • No carcinomatous meningitis or brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • White Blood Cell (WBC) ≥ 4,000/mm^3 OR
  • Granulocyte count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Serum Glutamic-Oxaloacetic Transaminase(SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) ≤ 2 times normal
  • Bilirubin ≤ 1.5 mg/dL

Renal

  • Creatinine ≤ 2.0 mg/dL OR
  • Creatinine clearance ≥ 50 mL/min

Cardiovascular

  • History of deep venous thrombosis allowed provided patients are maintained on therapeutic anticoagulation therapy
  • No active angina pectoris
  • No New York Heart Association class II-IV heart disease
  • No myocardial infarction within the past 6 months
  • No thrombosis within the past 3 months

Other

  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No active infection
  • No other concurrent serious medical illness that would preclude study participation
  • No other malignancy within the past 3 years except curatively treated basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since prior flutamide
  • At least 8 weeks since prior bicalutamide

Radiotherapy

  • More than 4 weeks since prior radiotherapy
  • No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium

Surgery

  • See Disease Characteristics

Other

  • Recovered from all prior therapy
  • No prior cytotoxic therapy for prostate cancer
  • No concurrent milk, milk products, antacids, calcium-containing drugs, or food during estramustine administration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084565

Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Gary R. Hudes, MD Fox Chase Cancer Center
  More Information

No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00084565     History of Changes
Other Study ID Numbers: FCCC-03035, CDR0000365459
Study First Received: June 10, 2004
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
stage IV prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Paclitaxel
Topotecan
Estramustine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on September 18, 2014