Vinflunine in Hormone Refractory Prostate Cancer (HRPC)
Currently, there are no established 2nd-line or salvage chemotherapy regimens for patients with HRPC, many of whom retain an excellent performance status. The antitumor characteristics and toxicity profile of vinflunine make it an ideal agent to be investigated in this setting. In this Phase II trial, we plan to evaluate the efficacy, toxicity, and feasibility of administering IV vinflunine at a dose of 320 mg/m2 q3w as salvage chemotherapy in patients with HRPC. The patients will be evaluated for response, survival, and toxicity. If significant antitumor activity is demonstrated, further evaluation of this agent either alone or combination regimens and at earlier stages of disease will be indicated.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Vinflunine as Salvage Chemotherapy in Hormone Refractory Prostate Cancer (HRPC)|
- PSA Response Rate, Defined as the Percentage of Patients With an Objective Decrease in PSA and/or Experience an Objective Benefit From Treatment. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Time to PSA Progression and Overall Survival Will be Summarized Via Kaplan-Meier-type Plots, and by Medians With Corresponding 95% CI. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
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
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 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.
|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|