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Leuprolide or Goserelin Plus Thalidomide Compared With Leuprolide or Goserelin Alone in Treating Patients With Nonmetastatic Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: July 11, 2001   Last Updated: April 11, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020085
  Purpose

RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Leuprolide and goserelin may fight prostate cancer by reducing the production of androgens. Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. It is not yet known whether leuprolide or goserelin plus thalidomide is more effective than leuprolide or goserelin alone for prostate cancer.

PURPOSE: This randomized phase III trial is studying leuprolide or goserelin plus thalidomide to see how well they work compared to leuprolide or goserelin alone in treating patients with nonmetastatic prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: goserelin
Drug: leuprolide acetate
Drug: thalidomide
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
Official Title: A Double Blind Randomized Crossover Phase III Study of Oral Thalidomide Versus Placebo in Patients With Stage D0 Androgen Dependent Prostate Cancer Following Limited Hormonal Ablation

Resource links provided by NLM:


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

Study Start Date: March 2000
Detailed Description:

OBJECTIVES:

  • Determine the potential clinical activity of oral thalidomide, in terms of time to progression, in patients with androgen-dependent nonmetastatic prostate cancer.
  • Evaluate the toxic effects of oral thalidomide in these patients after definitive therapy.
  • Determine whether changes in molecular markers of angiogenesis are observed in patients treated with this regimen.
  • Assess pharmacodynamic correlations between activity and toxicity of this regimen in these patients.

OUTLINE: This is a randomized, crossover, double-blind, placebo-controlled, multicenter study.

Patients with a rising prostate-specific antigen (PSA) are randomized to receive leuprolide or goserelin intramuscularly monthly for 6 months, followed by oral thalidomide or oral placebo daily. At the time of PSA progression, patients receive an additional 6 months of monthly leuprolide or goserelin therapy. After 6 months, patients originally treated with thalidomide are crossed over to the placebo arm or vice versa until PSA progression or development of metastatic disease is observed.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly until disease progression.

PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this study within 18 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed nonmetastatic (stage D0 by Jewett classification system; stage IV by TNM classification system) adenocarcinoma of the prostate

    • Must be prostate-specific antigen (PSA) only androgen dependent
    • Failed definitive therapy (radical prostatectomy, radiotherapy with external beam or brachytherapy, or cryosurgery)
    • No metastatic prostate cancer on CT scan or bone scan
  • Progressive disease defined as:

    • Two consecutively rising PSAs above the nadir post definitive therapy and greater than 1.0 ng/mL (at least 2 weeks apart)
  • Eligible for late entry provided the following are true:

    • Must have received leuprolide or goserelin within the past 3 months
    • No metastasis by bone scan and CT scan

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 12 months

Hematopoietic:

  • Granulocyte count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic:

  • Bilirubin no greater than 1 mg/dL (2.5 mg/dL for patients with Gilbert's syndrome)
  • ALT and AST less than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance greater than 40 mL/min

Cardiovascular:

  • No unstable angina pectoris
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class II-IV congestive heart failure

Pulmonary:

  • No chronic obstructive lung disease requiring oxygen therapy

Neurologic:

  • No peripheral neuropathy grade 2 or greater
  • No uncontrolled seizure disorders within the past 10 years

Other:

  • Patients must use a latex condom during and for 4 weeks after study participation
  • Fertile patients must use effective barrier contraception for 4 weeks before, during, and for 2 months after study participation
  • No other malignancy within the past 2 years except nonmelanoma skin cancer, carcinoma in situ, or Rai stage 0 chronic lymphocytic leukemia
  • No other life threatening illness
  • No uncontrolled infection
  • No psychiatric history of major depression, confirmed by psychiatrist

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior systemic chemotherapy for prostate cancer
  • At least 1 year since other prior cytotoxic chemotherapy
  • No concurrent cytotoxic chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 1 year since prior leuprolide*, diethylstilbestrol, flutamide, bicalutamide, goserelin*, finasteride, or nilutamide unless received as adjuvant or neoadjuvant therapy
  • No other concurrent leuprolide, diethylstilbestrol, flutamide, bicalutamide, goserelin, finasteride, or nilutamide NOTE: *Does not include patients enrolled under late entry criteria who have received leuprolide/goserelin within the past 3 months

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics
  • No prior bilateral surgical orchiectomy

Other:

  • At least 1 year since prior PC-SPES or sedative/hypnotics, unless received as adjuvant or neoadjuvant therapy
  • At least 1 week since prior IV antibiotics
  • No concurrent PC-SPES
  • No concurrent sedative or hypnotic agents (i.e., benzodiazepines)
  • No concurrent anticonvulsants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020085

Locations
United States, Louisiana
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
United States, Maryland
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Virginia
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Sponsors and Collaborators
Investigators
Study Chair: William Dahut, MD National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067700, NCI-00-C-0080, NCI-T99-0053
Study First Received: July 11, 2001
Last Updated: April 11, 2009
ClinicalTrials.gov Identifier: NCT00020085     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Anti-Infective Agents
Immunologic Factors
Thalidomide
Prostatic Diseases
Genital Neoplasms, Male
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Reproductive Control Agents
Anti-Bacterial Agents
Neoplasms by Site
Leuprolide
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Antineoplastic Agents, Hormonal
Growth Substances
Goserelin
Genital Diseases, Male
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Fertility Agents, Female
Fertility Agents
Prostatic Neoplasms
Leprostatic Agents

ClinicalTrials.gov processed this record on November 05, 2009