E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non small cell lung cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029520 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029521 |
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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 |
Evaluate Pemetrexed-cisplatino efficacy as induction therapy, followed by Pemetrexed-cisplatino with concomitatnt radiotherapy, in patients with NSCLC with non-squamous histology,without having surgery,local advanced stadium, evaluated through progression-free survival (PFS) at 1 year from the beginning of induction chemotherapy |
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E.2.2 | Secondary objectives of the trial |
- Objective rate of response or overall survival (OS)or Study therapy Safety and toxicity Profile |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients are eligible to be included in the study only if they meet all of the following criteria: [1] Histologic or cytologic diagnosis of unresectable nonsquamous Stage IIIA or Stage IIIB (without malignant pleural/pericardial effusions) NSCLC. Squamous cell and/or mixed small cell, non-small cell histology is not permitted. See Protocol Attachment S128.2, American Joint Committee on Cancer Staging Criteria for Lung Cancer; Greene et al. 2002. [2] Have an ECOG PS of 0 or 1. See Protocol Attachment S128.3 for details. [3] Previous radiation therapy is allowed, but should have been limited and must not have included thoracic radiation, whole pelvis radiation, or radiation to >25% of the patients bone marrow (Cristy and Eckerman 1987). Patients must have recovered from the toxic effects of radiation treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. [4] Have at least 1 unidimensionally measurable lesion meeting RECIST guidelines, version 1.0 (at least 10 mm in longest diameter by spiral CT scan, or at least 20 mm by standard techniques) (see Protocol Attachment S128.4; Therasse et al. 2000). Positron emission tomography (PET) scans and ultrasounds may not be used. [5] Estimated life expectancy of at least 12 weeks. [6] Patient compliance and geographic proximity that allow adequate follow-up. [7] Adequate organ function, including the following: Adequate bone marrow reserve: leukocytes 3.0  109/L, absolute neutrophil count (ANC) 1.5  109/L, platelets 100  109/L, and hemoglobin 9 g/dL. Hepatic: bilirubin 1.5 times the upper limit of normal ( ULN) and alkaline phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) 1.5  ULN. Patients with liver transaminases between 1 and 1.5  ULN must have no indication of liver metastases on contrast-enhanced CT scan. Renal: calculated creatinine clearance (CrCl) 45 mL/min based on the standard Cockroft and Gault formula (see Protocol Attachment S128.5) and serum creatinine 1.5  ULN. Pulmonary: forced expiratory volume in 1 second (FEV1) >50% of predicted normal volume and the carbon monoxide diffusing capacity (DLCO) >40% of predicted normal value. [8] Patients must sign an ICD. [9] Patients must be at least 18 years of age. [10] Patients must have completed a 3-D plan, and the attending physician must have reviewed and approved the dose volume histograms with a total lung V20 35%. [11] For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 6 months after the treatment period; must have a negative serum pregnancy test within 7 days before study enrollment and must not be breast-feeding. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period. [12] Have not received prior systemic anticancer therapy for NSCLC. No prior adjuvant chemotherapy is allowed. |
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E.4 | Principal exclusion criteria |
Patients will be excluded from the study if they meet any of the following criteria: [13] Have received treatment within the last 30 days of enrollment with a drug that has not received regulatory approval for any indication at the time of study entry. [14] Have previously completed or withdrawn from this study or any other study investigating pemetrexed. [15] Have a serious concomitant systemic disorder (e.g., active infection, including human immunodeficiency virus) that, in the opinion of the investigator, would compromise the patients ability to adhere to the protocol. [16] Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV (see Protocol Attachment S128.6). [17] Have had a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of low-grade (Gleason score 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously. [18] Are receiving concurrent administration of any other antitumor therapy. [19] Have had weight loss 10% over the previous 3 months before study entry. [20] Are unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose 1.3 grams per day, for at least 2 days before (5 days for long-acting agents [for example, piroxicam]), the day of, and for at least 2 days after administration of pemetrexed. [21] Are unable or unwilling to take folic acid or vitamin B12 supplementation. [22] Are unable or unwilling to take corticosteroids. [23] Have received a recent yellow fever vaccination (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination. [24] Have known hypersensitivity to pemetrexed, cisplatin, or any of the excipients in these medicinal products. [25] Have evidence of clinical hearing loss. [26] Have clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primario: sopravvivenza libera da progressione a 1 anno |
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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 | No |
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 | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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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ultima visita dell`ultimo paziente |
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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 | 6 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 6 |