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

Trial Conditions

  • Colorectal Cancer

Trial Interventions

DrugSynonymsArms
panitumumab

Trial 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

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, 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

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Both
Healthy Volunteers:No

Primary Outcome Measures

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
Safety Issue:No
Description:

Secondary Outcome Measures

Measure:To determine progression free survival, disease control rate and overall survival.
Time Frame:3 years
Safety Issue:No
Description:

Trial Keywords

  • panitumumab
  • cetuximab
  • KRAS wild-type