VECTIBIX PLUS OXALIPLATIN-BASED ADJUVANT TREATMENT OF RECTAL CANCER - VECTOX

• Conditions: Rectal cancer stage 2-3 includes neoadjuvant chemo radiation, followed by resection, followed by adjuvant chemotherapy.; MedDRA version: 12.1Level: LLTClassification code 10010033Term: Colorectal cancer stage II; MedDRA version: 12.1Level: LLTClassification code 10010034Term: Colorectal cancer stage III

• Registration Number: EUCTR2009-013756-79-GR
• Lead Sponsor: Anticancer Informing Me Gnosi Nika

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All the following must be met

•Written Informed consent
•Adult patients with resected rectal cancer, stage 2 and 3
•Wild-type kRAS tumor status
•Age > 18
•Adequate PS <2
•Resection of rectal cancer preceded by chemo-irradiation; there should be at least 3 weeks of postoperative recovery allowed before initiation of adjuvant treatment. If patients have not received preoperative chemoradiation, it should be administered postoperatively upon recovery from surgery. Enrollment in the protocol will take place following chemoirradiation (2-4 weeks after the last radiation administration).

•Laboratory Values

Haematology:
•Neutrophil count =1.5x109/L
•Platelet count =100x109/L
•Leucocytes count > 3,000/mm3
•Hemoglobin > 9mg/dL
Hepatic Function:
•Total bilirubin = 1.5 time the upper normal limit (UNL)
•AST (SGOT) = 2.5xUNL
•ALT (SGPT) = 2.5xUNL
•Renal Function
• Creatinine clearance =50 mL/min
•Metabolic Function
- Magnesium = lower limit of normal.
- Calcium = 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

Exclusion Criteria

•Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrollment/randomization
•History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
•Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
•Subject (male or female) is 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.
•Any significant co-morbidity precluding administration of adjuvant chemotherapy
•Patients who have previously received Vectibix or Cetuximab

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the feasibility and preliminary efficacy of adding standard dose panitumumab to standard dose adjuvant FOLFOX4 chemotherapy in patients with resected rectal cancer;Secondary Objective: Incidence of all grades, panitumumab-related toxicity<br>Incidence of grade 3 events<br>Relative dose intensity achieved (vectibix, oxaliplatin and 5FU)<br>Disease-free survival (DFS) at 2 years, starting from the first study drug administration<br>;Primary end point(s): Incidence of unacceptable toxicity (defined as grade 4 adverse event or any toxicity leading to discontinuation of therapy) of the combination of FOLFOX4-panitumumab, as per NCI-CTC guidelines, version 3