E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Limited Stage Small Cell Lung Cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10041069 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this phase II study is to estimate the overall response rate after treatment with pemetrexed + carboplatin (at doses of 500 mg/m2 and target AUC of 5, respectively) and concurrent radiation (up to a cumulative dose of 50 Gy) in patients with LS-SCLC. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of this phase II study include the following: Assess time-to-event for: o PFS o 1-year OS o duration of response Determine CR rate. Evaluate safety and further characterize acute and late toxicities. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
[1] Histologic and/or cytologic diagnosis of LS-SCLC, without cytological proven malignant pleural effusion and confined to 1 hemithorax [2] Performance status of 0 to 1 on the ECOG performance status schedule (Oken et al. 1982) [3] Measurable disease as defined by: At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST; Therasse et al. 2000) criteria (at least 10 mm in longest diameter by spiral computerized tomography [CT] scan, or at least 20 mm by standard techniques). Positron emission tomography (PET) scans and ultrasounds may not be used. [4] Adequate organ function, including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) >=1.5 × 109/L, platelets >=100 × 109/L, and haemoglobin >=9 g/dL. Hepatic: bilirubin <=1.5 times the upper limit of normal (× ULN); alkaline phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransaminase (ALT) <=3.0 × ULN. Renal: calculated creatinine clearance (CrCl) >=45 mL/min based on the standard Cockcroft and Gault formula [5] Adequate pulmonary function as defined as a forced expiratory volume in 1 sec (FEV1) >30% predicted normal value and diffusion capacity (DLCO) >40% predicted normal value. [7] 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 or urine pregnancy test within 7 days before study enrolment 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. |
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E.4 | Principal exclusion criteria |
[1] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. [2] 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 S095.6 New York Heart Association Classifications). [3] Diagnosis of a serious concomitant systemic disorder (for example, active infection including HIV) that, in the opinion of the investigator, would compromise the patient's ability to complete the study. [4] Have had a recent (within 30 days of study treatment) or concurrent yellow fever vaccination. [5] Have had a prior malignancy other than SCLC, carcinoma in situ of the cervix, or nonmelanoma 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. [6] Prior chemotherapy for this cancer and/or prior TRT [7] Pregnancy/breast-feeding. [8] Significant weight loss (that is >10%) over the previous 6 weeks before study entry. [9] Concurrent administration of any other anti-tumour therapy. [120] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose <=1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam). [11] Inability or unwillingness to take folic acid or vitamin B12 supplementation. [12] Inability to take corticosteroids. [13] Completion or withdrawal from this study or any other study investigating pemetrexed, carboplatin, and/or TRT. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |