Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Massachusetts General Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Amgen
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00842257
First received: February 10, 2009
Last updated: May 3, 2010
Last verified: May 2010

February 10, 2009
May 3, 2010
September 2010
March 2011   (final data collection date for primary outcome measure)
To determine the response rate of single agent panitumumab among patients with KRAS wild-type colorectal cancer previously treated with cetuximab. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00842257 on ClinicalTrials.gov Archive Site
To determine progression free survival, disease control rate and overall survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer
A Single Arm Phase II Trial of Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer

The purpose of this research study is to learn whether panitumumab helps treat colorectal cancer in participants who have not responded to treatment with cetuximab. Panitumumab is a human monoclonal antibody. Antibodies are proteins that recognize a foreign substance in the body and then attach themselves to it making it exposed to destruction. Panitumumab attaches itself to a protein on cancer cells called "epidermal growth factor receptor" or EGFR. EGFR helps cancer cells to grow, and blocking EGFR helps prevent cancer cells from growing.

  • Panitumumab will be given to the participants through a central line. A central line is a long, thin tube (catheter) that is inserted through the skin into a large vein in the chest. This is placed by a radiologist or surgeon.
  • Panitumumab will be given in 4-week cycles. Panitumumab infusions will be given on days 1 and 15 of each cycle (every 2 weeks).
  • The following procedures will be performed on days 1 and 15 of each cycle, before each infusion: physical exam; questions about any symptoms or side effects; performance status; routine blood tests and CT or MRI (every 2 cycles).
  • Participants can continue to receive panitumumab until their disease gets worse or they experience unacceptable side effects.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
Drug: panitumumab
Given by a central line infusion on days 1 and 15 of each 4-week cycle.
Not Provided
Wadlow RC, Hezel AF, Abrams TA, Blaszkowsky LS, Fuchs CS, Kulke MH, Kwak EL, Meyerhardt JA, Ryan DP, Szymonifka J, Wolpin BM, Zhu AX, Clark JW. Panitumumab in patients with KRAS wild-type colorectal cancer after progression on cetuximab. Oncologist. 2012;17(1):14. doi: 10.1634/theoncologist.2011-0452. Epub 2011 Dec 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
32
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and measurable disease by RECIST criteria on CT or MRI
  • Treated with cetuximab as part of their last treatment regimen for at least 4 weeks and must have been taken off cetuximab therapy for disease progression. Patients may or may not have been treated with 5-FU, oxaliplatin, irinotecan and bevacizumab. There is no maximal number of pre-existing treatment regimens. At least 2 weeks must have elapsed between previous anticancer therapy and the start of treatment on protocol, AND resolution of any skin rash related to prior treatment with epidermal growth factor receptor inhibitor
  • ECOG Performance Status 0, 1 or 2
  • Life expectancy of greater than 3 months
  • Normal organ, metabolic, and marrow function as defined in the protocol
  • A wild-type tumor K-RAS gene as determined by sanger sequencing of exon 2 from tumor DNA
  • 18 years of age or older

Exclusion Criteria:

  • History of untreated and or progression central nervous system metastases
  • History of another primary cancer except: curatively treated in situ cervical cancer or breast; curatively resected non-melanoma skin cancer; other primary solid tumor curatively treated with no known active disease present and no treatment administered for 3 years or more prior to enrollment
  • Intolerance to cetuximab leading to drug discontinuation due to rash, GI toxicity, or other grade 3 or 4 toxicities
  • Radiotherapy < 14 days prior to enrollment
  • Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies < 14 days before enrollment
  • Subjects requiring chronic use of immunosuppressive agents
  • Any investigational agent or therapy 30 days prior to enrollment
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with any study requirements
  • History of interstitial lung disease
  • Women who test positive for serum or urine pregnancy test or who are breast feeding
Both
18 Years and older
No
Contact: Aram Hezel, MD 617-643-3813
United States
 
NCT00842257
08-287, 20070602
Yes
Aram Hezel, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Amgen
Principal Investigator: Aram Hezel, MD Massachusetts General Hospital
Massachusetts General Hospital
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP