E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rectal cancer stage 2-3 includes neoadjuvant chemo radiation, followed by resection, followed by adjuvant chemotherapy. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010033 |
E.1.2 | Term | Colorectal cancer stage II |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010034 |
E.1.2 | Term | Colorectal cancer stage III |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the feasibility and preliminary efficacy of adding standard dose panitumumab to standard dose adjuvant FOLFOX4 chemotherapy in patients with resected rectal cancer |
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E.2.2 | Secondary objectives of the trial |
Incidence of all grades, panitumumab-related toxicity Incidence of grade 3 events Relative dose intensity achieved (vectibix, oxaliplatin and 5FU) Disease-free survival (DFS) at 2 years, starting from the first study drug administration
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Definition of the end of the trial is provided in the protocol. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |