Study Evaluating Toxicity & Efficacy of Lenalidomide(Revlimid®)in Chemotherapy-Naïve AIPC Patients

NCT00654186 | Completed Phase 2 Results

• 1 other identifier: RV-PCA-PI-327
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Androgen Independent Prostate Cancer (AIPC); Chemo naive

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Overall Clinical Benefit (OCB), Defined as the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Divided by the Number of Participants

  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. Prostate-Specific Antigen (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%.

  24 months for acrual

Secondary Outcomes (2)

• Time to PSA Progression

  24 months for acrual

• Time to Disesase Progression as Measured by Radiographic Progression

  24 months

Study Arms (1)

1

EXPERIMENTAL

Drug: Revlimid

Interventions

Revlimid DRUG

25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days

Also known as: Lenalidomide

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Oncology Specialists, S.C.: lead
• Celgene Corporation: collaborator

Study Sites (2)

Oncology Specialists, S.C

Niles, Illinois, 60714, United States

Location

Oncology Specialists, S.C

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Sigrun Hallmeyer, MD
• Organization: Oncology Specialists, SC

shallmeyer@oncmed.net

847-268-8200

Study Officials

• Chadi Nabhan, MD

  Oncology Specialists, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 28, 2014
• Results First Posted: February 28, 2014

Record last verified: 2014-02

Locations

US (2)