NCT00267007

Brief Summary

The purpose of this study is to evaluate the neuroprotective effect of PROCRIT (epoetin alfa, a glycoprotein that stimulates red blood cell production) versus placebo in patients with cancer who develop chemotherapy-induced peripheral neuropathy due to combination Taxane and Platinum-Based treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

28 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 7, 2009

Completed
Last Updated

June 4, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

December 16, 2005

Results QC Date

July 31, 2009

Last Update Submit

May 21, 2014

Conditions

Peripheral Neuropathy, Chemotherapy-induced

Keywords

Peripheral neuropathyChemotherapy-inducedHemoglobin levelCancerTaxanePlatinum-based chemotherapy

Outcome Measures

Primary Outcomes (1)

  • The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 1) at Week 12.

    NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy.

    Baseline to Week 12

Secondary Outcomes (1)

  • The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 2) at Week 12.

    baseline to Day 128

Study Arms (2)

001

EXPERIMENTAL

PROCRIT 40 000 IU QW Epoetin alpha (PROCRIT) 40 000 IU every week (QW) for 18 weeks (IV or SC)

Drug: PROCRIT 40,000 IU QW

002

PLACEBO COMPARATOR

Placebo Equivalent volume to PROCRIT (1 mL) administered (QW) for 18 weeks (IV or SC)

Drug: Placebo

Interventions

PROCRIT 40,000 IU QWDRUG

Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (IV or SC)

001
PlaceboDRUG

Equivalent volume to PROCRIT (1 mL) administered (QW) for 18 weeks (IV or SC)

002

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of cancer , and no history of peripheral neuropathy
  • Have had the appropriate surgery for carcinoma and are no more than 12 weeks post-operatively at study entry
  • Have not received chemotherapy (chemotherapy naïve patients) and are scheduled to receive at least 4 cycles of combination taxane and platinum-based chemotherapy
  • Have a hemoglobin value of \>= 10 and \< 12 g/dL
  • have a life expectancy of at least 6 months

You may not qualify if:

  • Patients who have had prior treatment with PROCRIT (epoetin alfa) or similar drugs (erythropoietic agents) within the last 2 months
  • Have used experimental treatments within the last year that are reported or hypothesized to have neuroprotective potential, including amifostine, cyanocobalamin (vitamin B12), alpha-tocopherol (Vitamin E), glutamine, and gabapentin
  • have anemia due to factors other than cancer/chemotherapy, or have ongoing neuropathy due to any cause
  • Received a transfusion of platelets or packed red blood cells within 28 days prior to the first dose of study medication
  • Have a history of pulmonary emboli, deep vein thrombosis, ischemic stroke or any other history of arterial or venous thrombotic events

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Unknown Facility

Mobile, Alabama, United States

Location

Unknown Facility

Little Rock, Arkansas, United States

Location

Unknown Facility

Alhambra, California, United States

Location

Unknown Facility

Bakersfield, California, United States

Location

Unknown Facility

Fullerton, California, United States

Location

Unknown Facility

La Verne, California, United States

Location

Unknown Facility

Long Beach, California, United States

Location

Unknown Facility

Northridge, California, United States

Location

Unknown Facility

Oxnard, California, United States

Location

Unknown Facility

Santa Maria, California, United States

Location

Unknown Facility

New Haven, Connecticut, United States

Location

Unknown Facility

Hollywood, Florida, United States

Location

Unknown Facility

Augusta, Georgia, United States

Location

Unknown Facility

Joliet, Illinois, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Bethesda, Maryland, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Southfield, Michigan, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Lebanon, New Hampshire, United States

Location

Unknown Facility

Buffalo, New York, United States

Location

Unknown Facility

Syracuse, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Chattanooga, Tennessee, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System DiseasesNeoplasms

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Limitations and Caveats

No formal analysis was conducted due to early termination

Results Point of Contact

Title
Vice President
Organization
Centocor Ortho Biotech Services, LLC (COBS)
215 325 4464

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2005

First Posted

December 20, 2005

Study Start

June 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

June 4, 2014

Results First Posted

September 7, 2009

Record last verified: 2014-05

Locations

US(28)