Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer

Completed · Phase 1/Phase 2

Conditions studied: Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage III Colon Cancer, Stage III Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

In brief

Monoclonal antibodies, such as pertuzumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving pertuzumab together with cetuximab may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of pertuzumab when given together with cetuximab and to see how well they work in treating patients with previously treated locally advanced or metastatic colorectal cancer

Key facts

Study ID

NCT00551421

Run by

National Cancer Institute (NCI)

People needed

17

Starts

2007-10-01

Expected to finish

2012-06-01

Last updated by the study team

2015-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a history of colorectal cancer (CRC) treated by surgical resection and who develop radiological or clinical evidence of metastatic disease do not require separate histological or cytological confirmation of metastatic disease unless 1 of the following criteria are met:
• More than 5 years has elapsed between the primary surgery and the development of metastatic disease
• The primary cancer was stage I
• Patients must have representative tumor specimens in paraffin blocks or at least 15 unstained slides with an associated pathology report obtained at any time prior to study entry:
• Cytology specimens are not acceptable replacements
• Patients must have their tumor tissue screened for KRAS mutation status, and be found to have a KRAS wild-type tumor:
• No KRAS-mutated tumor
• Locally advanced or metastatic disease
• Not curable by surgery or amenable to radiotherapy with curative intent
• Must have received an cetuximab-containing regimen for at least 6 weeks for treatment of metastatic disease
• Documented progression of disease or intolerable toxicity during or within 3 months of receiving this regimen
• Patients who have received an cetuximab-containing regimen as adjuvant therapy for resected stage II or III CRC are eligible provided recurrent disease is documented < 6 months after completion of adjuvant treatment
• Must have received >= 1 prior chemotherapeutic regimen for treatment of metastatic disease with any of the following:
• Cetuximab
• Must have resolution of any skin rash related to prior treatment with cetuximab
• No prior cetuximab which required a dose reduction for toxicity
• 5-fluorouracil or capecitabine
• Irinotecan hydrochloride or oxaliplatin
• Measurable disease by CT scan or physical exam
• ECOG performance status (PS) 0-1 (Karnofsky PS 70-100%)
• Life expectancy > 12 weeks
• Absolute neutrophil count >= 1,500/mcL
• Platelet count >= 100,000/mcL
• Leukocytes >= 3,000/mcL
• Hemoglobin >= 9 g/dL (transfusion, erythropoietin, or other approved hematopoietic growth factors allowed)

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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