Vinflunine in Hormone Refractory Prostate Cancer (HRPC)

NCT00545766 | Completed Phase 2 Results

• 1 other identifier: SCRI GU 35
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 12

Brief 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. 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Hormone Refractory; Vinflunine; Salvage Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Secondary Outcomes (3)

• Time to PSA Progression

  18 months

• Progression Free Survival

  18 months

• Number of Participants Experiencing Overall Survival (OS)

  18 months

Study Arms (1)

Interventional

EXPERIMENTAL

Drug: Vinflunine

Interventions

Vinflunine DRUG

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.

Also known as: Javlor

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Bristol-Myers Squibb: collaborator

Study Sites (12)

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Integrated Community Oncology Network

Jacksonville, Florida, 32256, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, 40207, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

Consultants in Medical Oncology and Hematology

Drexel Hill, Pennsylvania, 19026, United States

Location

Associates in Hematology Oncology

Chattanooga, Tennessee, 37404, United States

Location

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

South Texas Oncology and Hematology

San Antonio, Texas, 78258, United States

Location

Peninsula Cancer Institute

Newport News, Virginia, 23601, United States

Location

Related Publications (1)

• 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.

  PMID: 20158340 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

vinflunine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: John Hainsworth, MD
• Organization: Sarah Cannon Research Institute

asksarah@scresearch.net

1-877-691-7274

Study Officials

• John D. Hainsworth, M.D.

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 17, 2007
• Study Start: May 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2009
• Last Updated: December 16, 2021
• Results First Posted: April 4, 2013

Record last verified: 2021-12

Locations

US (12)