Study Evaluating Toxicity & Efficacy of Lenalidomide(Revlimid®)in Chemotherapy-Naïve AIPC Patients
This study has been completed.
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
First received: April 2, 2008
Last updated: January 15, 2014
Last verified: January 2014
This is a single institution, open label, phase II study in androgen-independent prostate cancer patients who are chemotherapy-naïve. Patients will receive Revlimid® 25 mg daily on Days 1-21 followed by 7 days of rest repeated every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion.
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Study Evaluating the Toxicity and Efficacy of Single Agent Lenalidomide (Revlimid®) in Chemotherapy-Naïve Androgen-Independent Prostate Cancer Patients
Primary Outcome Measures:
- To Determine the Overall Clinical Benefit of Revlimid® in Chemotherapy-naïve AIPC. The Overall Clinical Benefit (OCB) is Defined as the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Divided by the Number of Participants. [ Time Frame: 24 months for acrual ] [ Designated as safety issue: No ]
The OCB was assessed using Recist 1.0 as defined in the protocol. A CR was defined as the disappearance of all lesions. A PR was defined as > or equal to a 30% decrease in the sum of the longest diameter of measureable lesions, SD was defined < a 30% decrease in the sum of the longest diameter of measureable lesions and < a 20% increase in the sum of the longest diameter of measureable lesions. For a CR, PR or SD, there are no new lesions.
PSA was also evaluated. A PSA CR was a PSA < or equal to 4 ng/dl. A PSA PR was a PSA that decreased by > or equal to 50%. Stable PSA was defined as a PSA that increased >25% and decreased < 50%.
Secondary Outcome Measures:
- Time to PSA Progression [ Time Frame: 24 months for acrual ] [ Designated as safety issue: No ]
As defined in the protocol PSA progression was an increase of at least 25%
- Time to Disesase Progression as Measured by Radiographic Progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Progressive disease (PD) was determined, as outlined in the protocol, by using Recist 1.0. PD is defined as greater than or equal to a 20% increase in the sum of all measureable lesions or the apprearance of two new bone lesions or the appearnce of one new soft tissue lesion.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2012 (Final data collection date for primary outcome measure)
25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
Other Name: Lenalidomide
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Understand and voluntarily sign an informed consent form.
- Age 18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Documented prostate cancer regardless of Gleason score
- Patients should be considered hormone refractory and androgen independent. They must fail LHRH analogues, and anti-androgen withdrawal trial. Failure is confirmed by an increase in PSA value of 10% or more than the value immediately before, and confirmed by another assessment 2 weeks later that shows a further increase.
- Patients must have measurable disease either biochemically (using PSA) and/or using the RECIST criteria for visceral organ involvement and/or bone disease
- ECOG Performance Status of 2 or less.
- Adequate liver function tests with ALT/AST being < 3x normal, total bilirubin of 1.5 or less, and adequate renal function measured by a creatinine of 2.0 mg/dl or less. Alkaline phosphatase values are never exclusion criteria if it is deemed related to bone metastases.
Patients need to have adequate bone marrow function.
- ANC of 1000 or above,
- Hgb of 9.0 g/dl or above,
- Platelets of 100,000 or above. If other causes are affecting plts counts such as autoimmune disorders, patients are allowed on study. Patients with inadequate bone marrow function that is deemed related to bone marrow involvement with prostate cancer are allowed at the investigator's discretion.
- Patients with other malignancies are allowed as long as there is no evidence of the other malignancy present at entry time, and it has been 3 years or more since the treatment for the other disorder was completed.
- Patients with prior exposure to investigational therapies including vaccines are allowed on this study as long as their last exposure was 4 weeks prior to study entry. Erlotinib exposure and GM-CSF is not an exclusion criteria as it is not considered chemotherapy.
- Patients with known bone metastases are allowed to receive intravenous bisphosphonates such as aredia or zometa. Patients on oral bisphosphonates are also allowed.
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
- Patients must agree to use a latex condom during sexual contact with a female of childbearing potential, even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
- Prior systemic chemotherapy for AIPC. Investigational therapy such as vaccines, immunotherapy, and oral targeted agents such as erlotinib, sorafenib, or sunitinib are allowed.
- Prior exposure to lenalidomide
- Known HIV positive status
- Known brain metastases.
- Steroids are allowed concomitantly ONLY IF they are taken for another chronic medical condition (Such as COPD, Multiple sclerosis…etc)
- Presence of other malignancies, unless the last treatment received for any other malignancy was 3 years or more. Non-melanoma skin cancers are excluded.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- 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.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- Known positive for HIV or infectious hepatitis, type A, B or C
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654186
|Oncology Specialists, S.C
|Niles, Illinois, United States, 60714 |
|Oncology Specialists, S.C
|Park Ridge, Illinois, United States, 60068 |
Oncology Specialists, S.C.
||Chadi Nabhan, MD
||Oncology Specialists, SC
No publications provided
||Dr. Sigrun Hallmeyer, Principal Investigator, Oncology Specialists, S.C.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 2, 2008
|Results First Received:
||January 15, 2014
||January 15, 2014
||United States: Institutional Review Board
Keywords provided by Oncology Specialists, S.C.:
Androgen Independent Prostate Cancer (AIPC)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 11, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs