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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 Site Alabaster, Alabama  
Research Site Mesa, Arizona  
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Danbury, Connecticut  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Arlington Heights, Illinois  
Research Site Bloomington, Indiana  
Research Site Ashland, Kentucky  
Research Site Baton Rouge, Louisiana  
Research Site Baltimore, Maryland  
Research Site Beverly, Massachusetts  
Research Site Battle Kreek, Michigan  
Research Site Hattiesburg, Mississippi  
Research Site Branson, Missouri  
Research Site Grand Island, Nebraska  
Research Site Las Vegas, Nevada  
Research Site Belleville, New Jersey  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Charleston, South Carolina  
Research Site Aberdeen, South Dakota  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Abington, Virginia  
Research Site Auburn, Washington