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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.

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CC5013
Sponsored by
Celgene Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Androgen Independent Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Understand and voluntarily sign an informed consent form. Age > or = to 18 years at the time of signing the informed consent form. Able to adhere to the study visit schedule and other protocol requirements. Must have a histologic diagnosis of adenocarcinoma of the prostate. 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. 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. 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. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix II: ECOG Performance Status Scale). Exclusion Criteria: Metastatic prostate cancer Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L) Platelet count <100,000 cells/mm3 (100 x 109/L) Serum creatinine >2.5 mg/dL (221 mmol/L) Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN) Serum total bilirubin >2.0 mg/dL (34 mmol/L) 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. 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. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Prior > or = to grade 3 allergic reaction/hypersensitivity to thalidomide. Prior > or = to grade 3 rash or any desquamating (blistering) rash while taking thalidomide. Prior use of lenalidomide. Prior use of chemotherapy for androgen independent prostate cancer. Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy except LHRH agonists/antagonists. Known active Hepatitis C.

Sites / Locations

  • Alta Bates Cancer Center
  • Moffit Cancer Center
  • Dana Farber Cancer Institute
  • Cancer Institute of New Jersey
  • Roswell Park Cancer Institute
  • Seattle Cancer Care Alliance

Outcomes

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.

Full Information

First Posted
September 10, 2005
Last Updated
November 22, 2005
Sponsor
Celgene Corporation
Collaborators
Prologue Research International
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1. Study Identification

Unique Protocol Identification Number
NCT00179738
Brief Title
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.
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Terminated
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Celgene Corporation
Collaborators
Prologue Research International

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Androgen Independent Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CC5013
Primary Outcome Measure Information:
Title
To determine the activity of lenalidomide monotherapy in subjects with androgen independent prostate cancer (AIPC).
Secondary Outcome Measure Information:
Title
To evaluate the safety of lenalidomide monotherapy as treatment for subjects with AIPC.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Understand and voluntarily sign an informed consent form. Age > or = to 18 years at the time of signing the informed consent form. Able to adhere to the study visit schedule and other protocol requirements. Must have a histologic diagnosis of adenocarcinoma of the prostate. 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. 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. 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. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix II: ECOG Performance Status Scale). Exclusion Criteria: Metastatic prostate cancer Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L) Platelet count <100,000 cells/mm3 (100 x 109/L) Serum creatinine >2.5 mg/dL (221 mmol/L) Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN) Serum total bilirubin >2.0 mg/dL (34 mmol/L) 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. 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. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Prior > or = to grade 3 allergic reaction/hypersensitivity to thalidomide. Prior > or = to grade 3 rash or any desquamating (blistering) rash while taking thalidomide. Prior use of lenalidomide. Prior use of chemotherapy for androgen independent prostate cancer. Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy except LHRH agonists/antagonists. Known active Hepatitis C.
Facility Information:
Facility Name
Alta Bates Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Moffit Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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.

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