Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Leuprolide or Goserelin Plus Thalidomide Compared With Leuprolide or Goserelin Alone in Treating Patients With Nonmetastatic Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over NCI NCI-00-C-0080 NCI-T99-0053, T99-0053, NCT00020085

Objectives

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

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 12 months

Hematopoietic:

• Granulocyte count at least 1,000/mm³
• Platelet count at least 75,000/mm³

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

Expected Enrollment

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

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.

Gulley JL, Figg WD, Steinberg SM, et al.: A prospective analysis of the time to normalization of serum androgens following 6 months of androgen deprivation therapy in patients on a randomized phase III clinical trial using limited hormonal therapy. J Urol 173 (5): 1567-71, 2005.[PUBMED Abstract]

Gulley JL, Figg WD, Carter J, et al.: A prospective analysis of the time to normalization of serum testosterone (T) following 6 months of androgen deprivation therapy in patients on a randomized phase III clinical trial utilizing intermittent hormonal therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1592, 2003.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

William Dahut, MD, Protocol chair		Ph: 301-435-8183 Email: dahutw@mail.nih.gov

Registry Information
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
Trial Start Date		2000-03-02
Registered in ClinicalTrials.gov		NCT00020085
Date Submitted to PDQ		2000-02-29
Information Last Verified		2007-01-06

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