Clinical Trials /

Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer

NCT00842257

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer
  • Official Title: A Single Arm Phase II Trial of Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer

Clinical Trial IDs

  • ORG STUDY ID: 08-287
  • SECONDARY ID: 20070602
  • NCT ID: NCT00842257

Conditions

  • Colorectal Cancer

Interventions

DrugSynonymsArms
panitumumabVectibixPanitumumab

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
PanitumumabExperimentalPanitumumab administered by a central line infusion on days 1 and 15 of each 4 week cycle.
  • panitumumab

Eligibility 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 (5-Fluorouracil), 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 (Eastern Cooperative Oncology Group) 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 (Kirsten rat sarcoma viral oncogene homolog) 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response Rate of Single Agent Panitumumab Among Patients With KRAS Wild-type Colorectal Cancer Previously Treated With Cetuximab.
Time Frame:3 years
Safety Issue:
Description:The response rate of single agent panitumumab among patients with KRAS wild-type (Kirsten rat sarcoma viral oncogene homolog) colorectal cancer previously treated with cetuximab. Inclusive of three patients with clinical progression prior to first re-staging CT scans. Response rate evaluated using RECIST (Response Evaluation Criteria In Solid Tumors). Best overall response is recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). RECIST: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD (longest diameter) of target lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions

Secondary Outcome Measures

Measure:Median Progression Free Survival (PFS)
Time Frame:3 years
Safety Issue:
Description:The duration of time from start of treatment to time of radiologic disease progression per RECIST or death, or otherwise the date of last tumor assessment. Median PFS was calculated using Kaplan Meier suvival analysis. Progressive disease is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Measure:Median Overall Survival
Time Frame:3 years
Safety Issue:
Description:The duration of time from start of treatment to time of death or otherwise the date of last tumor assessment. Median survival was calculated using Kaplan Meier suvival analysis.
Measure:Disease Control Rate as Defined by RECIST Criteria
Time Frame:3 years
Safety Issue:
Description:Disease Control Rate as defined by RECIST criteria. The number patients achieving stable disease, partial response, or complete response at some point during follow-up.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Massachusetts General Hospital

Trial Keywords

  • panitumumab
  • cetuximab
  • KRAS wild-type

Last Updated

May 16, 2017