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
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: panitumumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm Phase II Trial of Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To determine progression free survival, disease control rate and overall survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: September 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: panitumumab
    Given by a central line infusion on days 1 and 15 of each 4-week cycle.
Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842257

Contacts
Contact: Aram Hezel, MD 617-643-3813

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02214
Principal Investigator: Aram Hezel, MD         
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Brian Wolpin, MD         
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Sanjay Jain, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Amgen
Investigators
Principal Investigator: Aram Hezel, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aram Hezel, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00842257     History of Changes
Other Study ID Numbers: 08-287, 20070602
Study First Received: February 10, 2009
Last Updated: May 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
panitumumab
cetuximab
KRAS wild-type

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies, Monoclonal
Cetuximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014