Prostate CancerPhase 2NCT00545766
Vinflunine in Hormone Refractory Prostate Cancer (HRPC)
A Phase 2 study testing Vinflunine in people with Prostate Cancer, run by SCRI Development Innovations, LLC at 12 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Vinflunine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2007to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men age 18 years of age or older who have HRPC are eligible for this study based on the following inclusion criteria:
- Histologically confirmed adenocarcinoma of the prostate.
- Progressive hormone refractory locally advanced or metastatic disease.
- (Definition of HRPC): Clinical or serological evidence of disease progression despite adequate anti-androgen therapy, documented by castrate levels of serum testosterone (<50 ng/mL).
- Patients on medical castration therapy should continue on treatment to maintain castrate levels of serum testosterone. Patients receiving anti-androgen or estrogen therapy should either be maintained on it, or have documented progression 4 weeks after withdrawal of all agents (except nilutamide and bicalutamide), which requires 6 weeks.
- Disease Progression, documented by any of the following:
Show all 18Show fewer
- PSA Progression, documented by an elevated PSA level (>5 ng/mL), which has risen serially from the baseline PSA value (PSA value #1) on two occasions, each at least 1 week apart (these will be considered PSA values #2 and #3). (Note: if the level of PSA value #3 is less than the level of PSA value #2, a subsequent PSA value must be obtained (PSA value #4) at least 1 week after PSA value #3 was measured. In order for this event to be considered a PSA progression, the level of this final PSA value (PSA value #4) must be greater than the PSA level that was observed for PSA value #2.
- Progressive metastatic prostate carcinoma, documented by computed tomography (CT), magnetic resonance imaging (MRI), or radiograph of non osseous lesions (see Section 7.2).
- Bone Scan Progression, documented by the appearance of at least one or more new lesions that are not believed to be secondary to tumor flare phenomenon.
- Patients with bone only disease must have a PSA level >=5 ng/mL; patients with stable lesions must have evidence of PSA progression. Patients must have radiographically or clinically demonstrable metastatic disease.
- Receipt of either 1 or 2 previous chemotherapy regimens; one of these regimens must have included docetaxel.
- ECOG performance status of 0-2.
- Adequate bone marrow function, defined by: white blood cells >=3,500/uL, hemoglobin >=8 g/dL, platelet count >=100,000/uL.
- Adequate renal function, defined by: serum creatinine <1.8 mg/dL, or calculated or measured creatinine clearance (GFR) of >=60 cc/min. Patients with a creatinine clearance of >30 mL/min but <60 mL/min may also be enrolled, but will require an initial adjusted dose (see Section 5.1)
- Adequate hepatic function, defined by: total bilirubin <1.5 x the upper limit of normal, AST <2 x the upper limit of normal.
- Patients must be able to comprehend the nature of the study and provide written informed consent.
- Partners of women of childbearing potential must use effective contraception while on treatment and for at least 3 months thereafter. Women of childbearing potential include females who have experienced menarche and have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not post-menopausal (i.e., amenorrhea >12 months).
- Patients on bisphosphonate therapy (at the discretion of the investigator).
Who cannot join
- History of other prior malignancy in the past 5 years (excluding resected basal cell or squamous cell skin cancer).
- History of second- or third-degree heart block, uncontrolled angina, uncontrolled hypertension, or recent myocardial infarction or congestive heart failure (New York Heart Association Class III-IV) within the past 6 months (see Appendix F)
- Cerebral vascular accident within the past 6 months.
- Peripheral neuropathy > grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
- Patients with rising PSA but no demonstrable metastases.
- Previous radiotherapy, outside of standard portals, utilized for prostate cancer (if total amount of radiotherapy encompasses >25% of bone marrow containing osseous regions).
Show all 12Show fewer
- Prior therapy with Strontium 90, Samarium 150, or other injectable therapeutic radioisotopes.
- History of prior allergic reaction to any vinca alkaloid.
- Use of chemotherapy or investigational drugs within 4 weeks prior to the first dose of study drug.
- Treatment with ketoconazole, itraconazole, ritonavir, amprenavir, or indinavir within 4 weeks prior to the first dose of study drug.
- Previous treatment with an anthracycline.
- Patients who are unable to receive chemotherapy on a basis of once every three weeks as a result of physical, environmental, or co existent medical problems.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Associates in Hematology Oncology
Chattanooga, Tennessee, 37404
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
Oncology Hematology Care
Cincinnati, Ohio, 45242
Consultants in Medical Oncology and Hematology
Drexel Hill, Pennsylvania, 19026
Florida Cancer Specialists
Fort Myers, Florida, 33901
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Integrated Community Oncology Network
Jacksonville, Florida, 32256
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
Peninsula Cancer Institute
Newport News, Virginia, 23601
Florida Hospital Cancer Institute
Orlando, Florida, 32804
South Texas Oncology and Hematology
San Antonio, Texas, 78258
About this study
Official title: A Phase II Trial of Vinflunine as Salvage Chemotherapy 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.
Read the detailed description
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.
Secondary Objectives
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.
- Conditions
- Prostate Cancer
- Being tested
- Vinflunine
- Keywords
- Prostate Cancer, Hormone Refractory, Vinflunine, Salvage Chemotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinflunineDrug
Also called Javlor
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Not described Receives: Drug: Vinflunine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein-specific Antigen (PSA) Response Rate
Defined as the percentage of patients with an objective decrease in PSA and/or experience an objective benefit from treatment.
Measured: 18 months
Secondary outcomes (3)
Time to PSA Progression
Time to PSA Progression is defined as the time from the first dose administration to the date when criteria for PSA progression (for Progressive Disease) are initially met.
Measured: 18 months
Progression Free Survival
Progression free survival is defined as the time from the first day of treatment until the day tumor progression was documented. Response categories were assigned after completion of two weeks of vinflunine therapy using Response Evaluation Criteria in Solid Tumors (RECIST). Progressive disease is defined as an increase in >=25% of of serum PSA above baseline value documented by at least two successive values separated by at least one week.
Measured: 18 months
Number of Participants Experiencing Overall Survival (OS)
OS is defined as the time from the first treatment until date of death due to any cause. In the absence of confirmation of death or lack of data beyond follow-up period, the survival time was censored to last date the participant was known to be alive. Number of participants experiencing overall survival is reported here.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- John D. Hainsworth, M.D., Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545766
- Sponsor's protocol ID
- SCRI GU 35
- Status last verified
- Dec 2021
- First submitted
- 15 Oct 2007
- Last updated
- 16 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hainsworth JD, Meluch AA, Lane CM, Spigel DR, Burris HA 3rd, Gandhi JG, Crane EJ, Stipanov MA, Greco FA. Single agent vinflunine in the salvage treatment of patients with castration-resistant prostate cancer: a phase II trial of the Sarah Cannon research consortium. Cancer Invest. 2010 Mar;28(3):275-9. doi: 10.3109/07357900902918460.
PubMed 20158340
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Vinflunine as Salvage Chemotherapy in Hormone Refractory Prostate Cancer (HRPC)
- ClinicalTrials.gov ID
- NCT00545766
- Acronym / sponsor ID
- SCRI GU 35
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Hormone Refractory, Vinflunine, Salvage Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- May 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Posted 4 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Secondary Objectives
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Drug: Vinflunine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Men age 18 years of age or older who have HRPC are eligible for this study based on the following inclusion criteria:
- Histologically confirmed adenocarcinoma of the prostate.
- Progressive hormone refractory locally advanced or metastatic disease.
- Disease Progression, documented by any of the following:
- Patients with bone only disease must have a PSA level >=5 ng/mL; patients with stable lesions must have evidence of PSA progression. Patients must have radiographically or clinically demonstrable metastatic disease.
Key exclusion criteria (12 listed)
- History of other prior malignancy in the past 5 years (excluding resected basal cell or squamous cell skin cancer).
- History of second- or third-degree heart block, uncontrolled angina, uncontrolled hypertension, or recent myocardial infarction or congestive heart failure (New York Heart Association Class III-IV) within the past 6 months (see Appendix F)
- Cerebral vascular accident within the past 6 months.
- Peripheral neuropathy > grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
- Patients with rising PSA but no demonstrable metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VinflunineAlso: JavlorVinflunine 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. | Drug | Interventional |
Primary outcome
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.
3 secondary outcomes
Time to PSA Progression
Time frame: 18 months
Progression Free Survival
Time frame: 18 months
Number of Participants Experiencing Overall Survival (OS)
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20158340Hainsworth JD, Meluch AA, Lane CM, Spigel DR, Burris HA 3rd, Gandhi JG, Crane EJ, Stipanov MA, Greco FA. Single agent vinflunine in the salvage treatment of patients with castration-resistant prostate cancer: a phase II trial of the Sarah Cannon research consortium. Cancer Invest. 2010 Mar;28(3):275-9. doi: 10.3109/07357900902918460.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D. Hainsworth, M.D. study chair
SCRI Development Innovations, LLC
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinflunine in people with Prostate Cancer, run by SCRI Development Innovations, LLC at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein-specific Antigen (PSA) Response Rate (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00545766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.