A Phase II Trial of Vinflunine as Salvage Chemotherapy in Hormone Refractory Prostate Cancer (HRPC)
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 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
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
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA Response Rate, Defined as the Percentage of Patients With an Objective Decrease in PSA and/or Experience an Objective Benefit From Treatment.
John D. Hainsworth, M.D.
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI GU 35
|Florida Hospital Cancer Institute||Orlando, Florida 32804|
|South Texas Oncology and Hematology||San Antonio, Texas 78229|
|Florida Cancer Specialists||Fort Myers, Florida 33901|
|Northeast Georgia Medical Center||Gainesville, Georgia 30501|
|Consultants in Blood Disorders and Cancer||Louisville, Kentucky 40207|
|Integrated Community Oncology Network||Jacksonville Beach, Florida 32250|
|Peninsula Cancer Institute||Newport News, Virginia 23601|
|Tennessee Oncology, PLLC||Clarksville, Tennessee 37043|
|Oncology Hematology Care||Cincinnati, Ohio 45242|
|Consultants in Medical Oncology and Hematology||Drexel Hill, Pennsylvania 19026|
|Chattanooga Oncology Hematology Associates||Chattanooga, Tennessee 37404|
|Associates in Hematology Oncology||Chattanooga, Tennessee 37404|