A phase 2 study of panitumumab in patients withcetuximab-refractory metastatic colorectal cancer - PACER

Conditions: metastatic colorectal cancer
MedDRA version: 13.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Registration Number: EUCTR2010-024490-39-IT

Lead Sponsor: ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

? Pathologic diagnosis of metastatic colorectal adenocarcinoma
? A wild-type tumor KRAS gene determined from tumor DNA
? Failure from previous treatment with fluoropirimidine, oxaliplatin and irinotecan.
Patients may or may not have been treated with bevacizumab.
? Documented disease progression following a treatment with cetuximab in patients
who showed either an objective response after 8 weeks or stable disease after 16
weeks of cetuximab treatment.
? Age 18 years
? ECOG Performance Status 0-2
? Neutrophils ? 1,5 x 109/L, platelets ? 100 x 109/L, and hemoglobin ? 9 g/dL
? Bilirubin level < 1.5 x ULN
? AST (SGOT) and ALT (SGPT) ? 2.5 x ULN (? 5 x ULN if liver metastasis are
present)
? Serum creatinine < 1.5 x ULN
? Effective contraception, if the risk of conception exists
? Life expectancy of greater than 3 months
? Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Symptomatic brain metastasis
? Interstitial pneumonitis or pulmonary fibrosis
? Any other malignancies within 5 years (except for adequately treated carcinoma
in situ of the cervix or non melanoma skin cancer)
? Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks
? Any unstable systemic disease (including active infections, any significant
hepatic, renal or metabolic disease), metabolic dysfunction, physical examination
finding, or clinical laboratory finding that contraindicates the use of study drugs or
render the patient at high risk from treatment complications.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess if panitumumab is active enough to warrant further<br>comparative studies in patients with metastatic colorectal cancer that has progressed<br>after treatment with cetuximab.;Secondary Objective: To describe: obiective responses, progression free survival, overall survival and toxicity<br><br>? To perform exploratory analysis of tumour-tissue for biological or genomic<br>determinants of outcome, including N-ras, BRAF and PI3K mutational status,<br>EGFR and PTEN expression status;Primary end point(s): Primary end-point is the rate of patients alive and non progressed at 2 months.

Secondary Outcome Measures