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Paclitaxel, Estramustine, and Thalidomide in Treating Patients With Progressive Metastatic Androgen-Independent Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00082693
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Combining thalidomide with chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining paclitaxel and estramustine with thalidomide in treating patients who have progressive metastatic androgen-independent prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: estramustine phosphate sodium
Drug: paclitaxel
Drug: thalidomide
Phase I
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Thalidomide Paclitaxel Estramustine Estramustine phosphate Estramustine phosphate sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma (Al-PCa)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2001
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of paclitaxel and thalidomide administered with estramustine in patients with progressive metastatic androgen-independent prostate cancer.
  • Determine the efficacy of this regimen in these patients.
  • Determine the objective response rate and prostate-specific antigen response rate in patients treated with this regimen.
  • Determine time to disease progression, performance status, analgesic consumption, and survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a phase I dose-escalation study of paclitaxel and thalidomide followed by a phase II study.

  • Phase I: Patients receive oral estramustine three times daily on days 1-5 and 8-12, oral thalidomide once daily on days 1-21, and paclitaxel IV over 3 hours on days 3 and 10. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of paclitaxel and thalidomide 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 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive paclitaxel, estramustine, and thalidomide as in arm I at the MTD.

PROJECTED ACCRUAL: A total of 48-75 patients (18 for phase I and 30-57 for phase II) will be accrued for this study within 8-15 months.

  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

    • Biopsy of a metastatic site allowed provided the tissue stains positive for prostate-specific antigen (PSA)
    • Indicator lesions need not be biopsy proven if the clinical presentation is characteristic
    • Nodal and/or visceral disease allowed NOTE: *Variant histologies (e.g., ductal carcinoma and small cell carcinoma) are allowed only for the phase I portion of the study
  • Progressive androgen-independent disease, as evidenced by the following:

    • Testosterone ≤ 50 ng/dL OR prior bilateral orchiectomy

      • Patients must continue luteinizing hormone-releasing hormone agonists to maintain castrate levels
    • Symptomatic progression OR rising PSA on two occasions, at least 1 week apart, with a minimum pretreatment PSA of 5 ng/mL
  • Progressive disease after at least 1, but no more than 2, prior chemotherapy regimens for prostate cancer in the neoadjuvant or metastatic setting (phase II only)
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL

Hepatic

  • SGOT and SGPT < 2 times upper limit of normal (ULN)
  • Bilirubin < 2 times ULN

Renal

  • Creatinine ≤ 2.0 mg/dL OR
  • Creatinine clearance ≥ 35 mL/min

Cardiovascular

  • No clinical history of heart disease
  • ECG normal OR
  • Ejection fraction ≥ 45% by echocardiogram, MUGA, or ventriculography

Other

  • No active or uncontrolled infection
  • No significant psychiatric disorder that would preclude giving informed consent
  • No grade 2 or greater peripheral neuropathy
  • No other malignancy within the past 5 years except superficial bladder cancer or basal cell skin cancer
  • No other serious medical illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 2 weeks since prior immunotherapy AND evidence of disease progression
  • More than 2 weeks since prior antiangiogenesis therapy AND evidence of disease progression

Chemotherapy

  • See Disease Characteristics
  • No more than 2 prior chemotherapy* regimens for prostate cancer
  • More than 3 weeks since prior chemotherapy and recovered
  • Prior taxanes allowed NOTE: *Ketoconazole is considered chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since prior flutamide or nilutamide (6 weeks for bicalutamide) AND no evidence of response or disease progression since withdrawal
  • No concurrent antiandrogens (e.g., flutamide, nilutamide or bicalutamide)

Radiotherapy

  • More than 12 weeks since prior strontium chloride Sr 89

    • No more than 1 prior dose of strontium chloride Sr 89
  • More than 3 weeks since prior radiotherapy
  • No prior radiotherapy to more than 15% of the bone marrow

Surgery

  • See Disease Characteristics
  • At least 2 weeks since prior surgery

Other

  • More than 2 weeks since prior non-androgen mediated pathway therapy (e.g., epidermal growth factor receptor antagonists or farnesyl transferase inhibitors) AND evidence of disease progression
  • More than 2 weeks since prior herbal or alternative medicines or PC-SPES AND evidence of disease progression
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082693

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Danai Daliani M.D. Anderson Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000355825, MDA-ID-00087
Study First Received: May 14, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00082693  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Thalidomide
Prostatic Diseases
Genital Neoplasms, Male
Paclitaxel
Estramustine
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence
Carcinoma

Additional relevant MeSH terms:
Anti-Infective Agents
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on January 15, 2009