Vinflunine in Hormone Refractory Prostate Cancer (HRPC)
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|ClinicalTrials.gov Identifier: NCT00545766|
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : April 4, 2013
Last Update Posted : April 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Vinflunine||Phase 2|
This is a non-randomized (single-arm), open-label, multi-center, single-agent, Phase II study of vinflunine as second- or third-line treatment of subjects with HRPC. The primary objective of the study is to evaluate the efficacy of vinflunine in the salvage treatment, as measured by Protein-Specific Antigen (PSA) Response Rate endpoint.
The primary objective of this study is as follows:
To evaluate the efficacy (as measured by the PSA response rate) of IV vinflunine administered q3w in HRPC patients who have progressed after one or two previous chemotherapy regimens.
The secondary objectives of this study are as follows:
To evaluate the efficacy of IV vinflunine administered q3w in HRPC patients who have previously received chemotherapy (one or two regimens), as measured by:
- Time to PSA progression
- Overall survival
- Palliative response in patients with an Analgesic Score (AS) ≥10 and stable baseline pain
- Health-Related Quality of Life
- To assess the efficacy (as measured by the PSA response rate) of IV vinflunine in HRPC patients based on their response to prior chemotherapy
- Chemotherapy responsive - previous response to most recent chemotherapy regimen lasting >2 months after completion.
- Chemotherapy refractory - failure to respond to, or progression during or within three months of completing last chemotherapy.
- To assess the response rate to IV vinflunine in the subset of patients with measurable disease, as measured by traditional Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Therasse et al. 2000).
- To evaluate the safety of IV vinflunine administered every three weeks in HRPC patients who have previously received chemotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Vinflunine as Salvage Chemotherapy in Hormone Refractory Prostate Cancer (HRPC)|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2009|
Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
Other Name: Javlor
- Protein-specific Antigen (PSA) Response Rate [ Time Frame: 18 months ]Defined as the percentage of patients with an objective decrease in PSA and/or experience an objective benefit from treatment.
- Time to PSA Progression and Overall Survival Will be Summarized Via Kaplan-Meier-type Plots, and by Medians With Corresponding 95% Confidence Interval (CI). [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545766
|United States, Florida|
|Florida Cancer Specialists|
|Fort Myers, Florida, United States, 33901|
|Integrated Community Oncology Network|
|Jacksonville, Florida, United States, 32256|
|Florida Hospital Cancer Institute|
|Orlando, Florida, United States, 32804|
|United States, Georgia|
|Northeast Georgia Medical Center|
|Gainesville, Georgia, United States, 30501|
|United States, Kentucky|
|Consultants in Blood Disorders and Cancer|
|Louisville, Kentucky, United States, 40207|
|United States, Ohio|
|Oncology Hematology Care|
|Cincinnati, Ohio, United States, 45242|
|United States, Pennsylvania|
|Consultants in Medical Oncology and Hematology|
|Drexel Hill, Pennsylvania, United States, 19026|
|United States, Tennessee|
|Associates in Hematology Oncology|
|Chattanooga, Tennessee, United States, 37404|
|Chattanooga Oncology Hematology Associates|
|Chattanooga, Tennessee, United States, 37404|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37023|
|United States, Texas|
|South Texas Oncology and Hematology|
|San Antonio, Texas, United States, 78258|
|United States, Virginia|
|Peninsula Cancer Institute|
|Newport News, Virginia, United States, 23601|
|Study Chair:||John D. Hainsworth, M.D.||SCRI Development Innovations, LLC|