Lenalidomide and Cyclophosphamide in Treating Patients With Previously Treated Hormone-Refractory Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01093183|
Recruitment Status : Unknown
Verified April 2014 by Jue Wang, MD, University of Nebraska.
Recruitment status was: Active, not recruiting
First Posted : March 25, 2010
Last Update Posted : April 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate Hormone-resistant Prostate Cancer Recurrent Prostate Cancer||Drug: lenalidomide Drug: cyclophosphamide Other: laboratory biomarker analysis Procedure: quality-of-life assessment Other: questionnaire administration||Phase 1 Phase 2|
I. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of lenalidomide administered in combination with oral cyclophosphamide.
I. To evaluate the objective prostate-specific antigen (PSA) response (50% decrease in PSA levels sustained for at least 4 weeks) as defined by PSA working group criteria; or a decrease in absolute PSA or a decrease in PSA velocity, increase in PSA doubling time, duration of any responses.
II. To explore the anti-tumor activity of the combination of lenalidomide plus oral cyclophosphamide in patients with previously treated hormone refractory prostate cancer.
III. To evaluate baseline and change of quality of life, particularly, bone pain and analgesic consumption, of the patients on this combination chemotherapy.
I. To determine whether related cytokines and biomarkers (serum levels of tumor necrosis factor-alpha, basic fibroblast growth factor, vascular endothelial growth factor [VEGF], T cell inhibitory activity, phytohemagglutinin [PHA] and interleukin [IL]-2, mononuclear cell isolation, VEGF, basic fibroblast growth factor [bFGF], IL-6) can help predict response to patients undergoing treatment with lenalidomide and cyclophosphamide.
OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II study.
Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.
After completion of study treatment, patients are followed up periodically.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Clinical Trial of Lenalidomide in Combination With Oral Cyclophosphamide in Patients With Previously Treated Hormone Refractory Prostate Cancer|
|Study Start Date :||March 2010|
|Primary Completion Date :||February 2014|
Experimental: Treatment (lenalidomide and cyclophosphamide)
Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.
Other Names:Drug: cyclophosphamide
Other Names:Other: laboratory biomarker analysis
Correlative studiesProcedure: quality-of-life assessment
Other Name: quality of life assessmentOther: questionnaire administration
- Maximum tolerated dose of lenalidomide administered in combination with oral cyclophosphamide (Phase I) [ Time Frame: 28 days ]Defined to be the dose cohort below which 2 of 3 or 3 of 6 patients experience dose-limiting toxicities in course 1 or the highest dose cohort of 25 mg.
- Proportion of patients achieving objective PSA response (50% decrease in PSA levels sustained for at least 4 weeks) as defined by PSA working group criteria [ Time Frame: 4 weeks ]
- Anti-tumor activity as assessed by the sum of complete response (CR), partial response (PR), and stable disease (SD) measured by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 4 months ]
- Proportion of patients achieving CR [ Time Frame: At 4 months ]Reported with the associated 95% confidence interval.
- Proportion of patients achieving a CR or PR (overall response rate) [ Time Frame: At 4 months ]Reported with the associated 95% confidence interval.
- Event-free survival [ Time Frame: Up to 5 years ]Estimated using the Kaplan-Meier method.
- Overall survival [ Time Frame: Up to 5 years ]Estimated using the Kaplan-Meier method.
- Change in quality of life [ Time Frame: At baseline and 8 weeks ]Assessed using the disease-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) version 3.0 and the Prostate Cancer Module for the QLQ-C30 (PR-25) questionnaire (with 1 being not at all and 4 being very much).
- Change in bone pain as assessed by the McGill Pain Questionnaire-Short Form (MPQ-SF) (Phase II) [ Time Frame: At baseline and every course for 4 months ]Pain intensity assessed by a 4 point pain intensity scale (with 0 being no pain and 3 being severe pain), pain degree assessed on a 0 to 10 numerical scale, and present pain intensity assessed on 0 to 5 scale (with 0 being no pain and 5 being excruciating).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093183
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Jue Wang||University of Nebraska|