A Multicenter, Single-Arm, Open-Label, Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid, CC-5013) in Subjects With Androgen Independent Prostate Cancer.

This study has been terminated.
Sponsor:
Collaborator:
Prologue Research International
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00179738
First received: September 10, 2005
Last updated: November 22, 2005
Last verified: September 2005
  Purpose

Subjects who qualify will receive single agent oral lenalidomide daily on days 1-21 every 28 day cycle. Subjects will continue on study until documented disease progression


Condition Intervention Phase
Prostate Cancer
Drug: CC5013
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Single-Arm, Open-Label, Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®) In Subjects With Androgen Independent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • To determine the activity of lenalidomide monotherapy in subjects with androgen independent prostate cancer (AIPC).

Secondary Outcome Measures:
  • To evaluate the safety of lenalidomide monotherapy as treatment for subjects with AIPC.

Estimated Enrollment: 40
Study Start Date: April 2005
Estimated Study Completion Date: April 2007
  Eligibility

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

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form.
  2. Age > or = to 18 years at the time of signing the informed consent form.
  3. Able to adhere to the study visit schedule and other protocol requirements.
  4. Must have a histologic diagnosis of adenocarcinoma of the prostate.
  5. Must be surgically or medically castrated. If the method is medical castration, the subject must have a serum testosterone level of <50 ng/dl. The subject should maintain treatment with LH RH antagonists or agonists.
  6. Must have prostate cancer unresponsive or refractory to androgen blockade as demonstrated by rising PSA.

    -Rising PSA is defined as at least 2 consecutive rises in PSA to be documented over the reference value (measure 1). The first rising PSA (measure 2) must be taken at least 7 days after the reference value.

    A third confirmatory PSA is required, and it must be obtained at least seven days after the second measure. If this is not greater than measure 2, a fourth PSA is required and this must be greater than measure 2.

    -Absolute value of PSA > or = to 5 ng/ml on the last confirmatory assessment.

  7. Prior treatment with antiandrogens such as flutamide, or other hormonal agents such as estrogens, corticosteroids, or ketoconazole must have been stopped for at least 28 days prior to treatment.

    In the case of nilandron and bicalutamide, treatment with these agents must have stopped at least 42 days prior to treatment. Following completion of the antiandrogen withdrawal period, either:

    • One post withdrawal PSA value must be higher than the last pre-withdrawal PSA value, or
    • If the subject s PSA value decreased following the antiandrogen withdrawal period then two increases in PSA values must be documented after the post-withdrawal nadir.
  8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix II: ECOG Performance Status Scale).

Exclusion Criteria:

  1. Metastatic prostate cancer
  2. Any of the following laboratory abnormalities:

    1. Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)
    2. Platelet count <100,000 cells/mm3 (100 x 109/L)
    3. Serum creatinine >2.5 mg/dL (221 mmol/L)
    4. Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
    5. Serum total bilirubin >2.0 mg/dL (34 mmol/L)
  3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret data from the study.
  4. Prior history of malignancies other than AIPC (except for basal cell or squamous cell carcinoma of the skin) unless the subject has been free of the disease for > or = to 1 year.
  5. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  6. Prior > or = to grade 3 allergic reaction/hypersensitivity to thalidomide.
  7. Prior > or = to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
  8. Prior use of lenalidomide.
  9. Prior use of chemotherapy for androgen independent prostate cancer.
  10. Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy except LHRH agonists/antagonists.
  11. Known active Hepatitis C.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179738

Locations
United States, California
Alta Bates Cancer Center
Berkeley, California, United States, 94704
United States, Florida
Moffit Cancer Center
Tampa, Florida, United States, 33612
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Celgene Corporation
Prologue Research International
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00179738     History of Changes
Other Study ID Numbers: CC-5013-PC-001
Study First Received: September 10, 2005
Last Updated: November 22, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Androgen Independent Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Lenalidomide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014