Phase 2, Open-label Trial of Skin Toxicity Treatment in mCRC Subjects Receiving Panitumumab + Irinotecan-based Therapy (STEPP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00332163
First received: May 31, 2006
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

A comparison of prophylactic treatment with reactive treatment for skin toxicity observed in patients with metastatic colorectal cancer (mCRC) who are receiving second-line irinotecan-based chemotherapy concomitantly with panitumumab.


Condition Intervention Phase
Metastatic Colorectal Cancer
Skin Rash
Skin Toxicities
Colon Cancer
Colorectal Cancer
Drug: Panitumumab
Drug: Irinotecan
Drug: FOLFIRI
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Incidence of specific grade 2 or greater skin toxicities during the 6-week skin treatment period. [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of grade 2 or greater skin toxicities of any type. [ Time Frame: six weeks ] [ Designated as safety issue: No ]
  • Time to first occurrence of specific grade 2 or greater skin toxicities of interest. [ Time Frame: six weeks ] [ Designated as safety issue: No ]
  • Most severe specific grade 2 or greater skin toxicities of interest. [ Time Frame: six weeks ] [ Designated as safety issue: No ]
  • Time to the most severe specific grade 2 or greater skin toxicities of interest. [ Time Frame: six weeks ] [ Designated as safety issue: No ]
  • Incidence of panitumumab dose reduction due to the specific skin toxicities of interest. [ Time Frame: six weeks ] [ Designated as safety issue: No ]
  • Response Rate at Week 9 for the FOLFIRI and panitumumab Q2W regimen with confirmed response at Week 13 or at Week 10 for the irinotecan and panitumumab Q3W regimen with confirmed response at Week 14. [ Time Frame: Weeks 9 through 14. ] [ Designated as safety issue: No ]
  • Best Overall Response Rate [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Progression-free Survival [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Rate of Disease Control at Week 9 for the FOLFIRI and panitumumab Q2W regimen with confirmed response at Week 13, at Week 10 for the irinotecan and panitumumab Q3W regimen with confirmed response at Week 14, or stable disease at Weeks 9 and 10. [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Time-to-treatment Failure [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes Endpoints [ Time Frame: unknown ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: April 2006
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Irinotecan Q3W pre-emptive
Irinotecan Q3W + Panitumumab, pre-emptive skin treatment
Drug: Panitumumab
Panitumumab 9mg/kg Q3W
Drug: Irinotecan
Irinotecan
Experimental: Irinotecan Q3W reactive
Irinotecan Q3W + Panitumimab, reactive skin treatment
Drug: Panitumumab
Panitumumab 9mg/kg Q3W
Drug: Irinotecan
Irinotecan
Experimental: Folfiri Q2W Pre-emptive
Folfiri Q2W + Panitumumab, pre-emptive skin treatment.
Drug: FOLFIRI
Irinotecan with infusional 5-fluorouracil and leucovorin
Drug: Panitumumab
Panitumumab 6 mg/kg Q2W
Experimental: Folfiri Q2W reactive
Folfiri Q2W + Panitumumab, reactive skin treatment
Drug: FOLFIRI
Irinotecan with infusional 5-fluorouracil and leucovorin
Drug: Panitumumab
Panitumumab 6 mg/kg Q2W

Detailed Description:

A phase 2, open-label, randomized clinical trial comparing prophylactic treatment with reactive treatment for skin toxicity in subjects with metastatic colorectal cancer receiving second-line treatment with either FOLFIRI (Ironotecan plus 5-FU plus leucovorin) or Irinotecan-only chemotherapy, concomitantly with panitumumab.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: • Patients with 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; • Patients who have failed 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332163

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00332163     History of Changes
Other Study ID Numbers: 20050184
Study First Received: May 31, 2006
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Amgen:
STEPP
STEP
STEEP
mCRC
Skin Toxicities
Skin Rash
Metastatic Colorectal Cancer
Anti-EGFr Skin Rash
colon cancer
colorectal cancer
rectal cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Exanthema
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Skin Diseases
Irinotecan
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014