A SINGLE-ARM, MULTICENTER, PHASE II STUDY OF PANITUMUMAB IN COMBINATION WITH CAPECITABINE / OXALIPLATIN IN FIRST-LINE, WILD-TYPE K-RAS METASTATIC COLORECTAL CANCER PATIENTS
- Conditions
- Wild-type K-ras metastatic colorectal cancerMedDRA version: 12.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer
- Registration Number
- EUCTR2009-012655-26-GR
- Lead Sponsor
- Hellenic Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Patients will be eligible to participate in the study if they meet all of the criteria listed below:
1.Ability to comprehend and sign an informed consent
2.Aged 18 years or more
3.Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum
4.Measurable disease according to the RECIST criteria
5.Eastern Cooperative Oncology Group (ECOG) status of 0-2
6.Non-mutated k-ras gene (k-ras status will be assessed by DNA sequencing in codons 12 and 13)
7.Haematologic function: ANC >1.5 x 109/L, Leucocyte count >3000/mm3, Haemoglobin >10g/ d L, PLT >100 x 109/ L
8.Renal function: serum creatinine =1.5xUNL or creatinine clearance > 50ml/min
9.Hepatic function:
oTotal bilirubin = 1.5 time the upper normal limit (UNL)
oASAT = 2.5xUNL in absence of liver metastases, or =5xUNL in presence of liver metastases
oALAT = 2.5xUNL in absence of liver metastases, or =5xUNL in presence of liver metastases
10. Metabolic function:
oMagnesium = lower limit of normal.
oCalcium = lower limit of normal.
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
Any patient with any of the criteria listed below will be excluded from the study:
1.Central nervous system metastases
2.Prior therapy for metastatic disease
3.Adjuvant chemotherapy for the last 6 months
4.Prior anti-EGFR therapy or treatment with EGFR tyrosine kinase inhibitors
5.Prior radiotherapy within 30 days from enrollment
6. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) £ 1 year before enrollment
7. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
8.Inflammatory bowel disease or chronic diarrhea
9.Dihydropyrimidine deficiency
10.Positive test for HIV infection, hepatitis C infection, chronic active hepatitis B infection
11.Any kind of disorder compromising the ability of the patient to give informed consent
12.Any investigational agent within 30 days prior to initiation of the study
13.Any surgical procedure within 28 days prior to initiation of the study
14. Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
15. Female subject in childbearing age with a positive pregnancy test at screening or before initiation of study treatment.
16. Subject (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To estimate the objective response rate in wild-type k-ras, metastatic colorectal cancer patients treated with panitumumab in combination with capecitabine/oxaliplatin as first-line therapy. ;Secondary Objective: Evaluation of<br>1. The progression-free survival<br>2. The overall survival<br>3. The safety profile<br>4. The total cost of the combination ;Primary end point(s): The objective response rate (ORR) in patients with wild-type k-ras metastatic colorectal cancer
- Secondary Outcome Measures
Name Time Method