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STEPP: A Phase 2, Open-label, Randomized Clinical Trial of Skin Toxicity Treatment in Subjects Receiving Second-line FOLFIRI or Irinotecan Only Chemotherapy Concomitantly With Panitumumab


Phase 2
18 Years
90 Years
Open (Enrolling)
Both
Metastatic Colorectal Cancer, Skin Rash, Skin Toxicities, Colon Cancer, Colorectal Cancer

Thank you

Trial Information

STEPP: A Phase 2, Open-label, Randomized Clinical Trial of Skin Toxicity Treatment in Subjects Receiving Second-line FOLFIRI or Irinotecan Only Chemotherapy Concomitantly With Panitumumab


Inclusion Criteria:

• Unresectable metastatic adenocarcinoma of the colon or rectum that
cannot, in the opinion of the investigator, be cured by surgical resection at the time of
randomization; • Failure of first line treatment containing fluoropyrimidine and
oxaliplatin based chemotherapy with or without bevacizumab for mCRC.

Exclusion Criteria: • Prior irinotecan use for the treatment of mCRC.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of specific grade 2 or greater skin toxicities during the 6-week skin treatment period.

Outcome Time Frame:

six weeks

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20050184

NCT ID:

NCT00332163

Start Date:

April 2006

Completion Date:

September 2008

Related Keywords:

  • Metastatic Colorectal Cancer
  • Skin Rash
  • Skin Toxicities
  • Colon Cancer
  • Colorectal Cancer
  • STEPP
  • STEP
  • STEEP
  • mCRC
  • Skin Toxicities
  • Skin Rash
  • Metastatic Colorectal Cancer
  • Anti-EGFr Skin Rash
  • colon cancer
  • colorectal cancer
  • rectal cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Exanthema

Name

Location

Research SiteAlabaster, Alabama  
Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteAshland, Kentucky  
Research SiteBaton Rouge, Louisiana  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteHattiesburg, Mississippi  
Research SiteBranson, Missouri  
Research SiteGrand Island, Nebraska  
Research SiteLas Vegas, Nevada  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteAberdeen, South Dakota  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington