E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
IIIB and IV 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 | 10026532 |
E.1.2 | Term | Malignant neoplasm of thorax |
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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 |
The principal objective of the trial is to assess which is the proper time interval between pemetrexed and gemcitabine administration to optimize the synergism between the two drugs in the treatment of patients with advanced NSCLC. |
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E.2.2 | Secondary objectives of the trial |
Evaluation of tumor response rate. Evaluation of Toxicity. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Histologically or citologically proven IIIB and IV non-small cell lung cancer. - Absence of symptomatic uncontrolled brain metastasis - Not suitable for platinum containing regimens if chemo-na ve or pretreated with regimens not containing Gemcitabine or Pemetrexed - A life expectancy of at least 12 weeks - Adequate bone marrow platelets 8805; 100 000 cells/L, absolute neutrophil count 8805; 1.5 x 109 cells/L, hemoglobin 8805; 9 g/dL. - Hepatic total bilirubin 8804; 1.5 times the upper limit of normal 61620; ULN , alkaline phosphatase AP , aspartate transaminase AST and alanine transaminase ALT 8804; 61472;3 61620; ULN AP, AST, and ALT 8804; 5 61620; ULN is acceptable if liver has tumor involvement . - Renal calculated creatinine clearance CrCl 8805; 45 mL/min based on the standard Cockroft and Gault formula or on measured glomerular filtration rate GFR using the appropriate radiolabeled method 51-CrEDTA or Tc99m-DTPA . Enrollment and dosing decisions based on creatinine clearance will be made using local lab values calculated using the standard Cockroft and Gault formula. The same method should be used throughout the study. |
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E.4 | Principal exclusion criteria |
- Pregnant and/or lactating women are not allowed in this treatment. Male and female patients with reproductive potential must use an approved contraceptive method if appropriate for example, intrauterine device IUD , birth control pills, or barrier device during and for 3 months after the study. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment. - Prior radiation to 25 of bone marrow - Inability to interrupt Aspirin at doses of 1.3 g/day or non-steroidal anti-inflammatory agents for a 5-day period 8-day period for long-acting agents, such as piroxicam . - Presence of clinically relevant 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. - Inability or unwillingness to take folic acid or vitamin B12. - Inability to take corticosteroids. - Diagnosis of myocardial infarction or significant cardiac disease - Have received treatment within the last 30 days with a drug not including study drug that has not received regulatory approval for any indication at the time of study entry. |
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E.5 End points |
E.5.1 | Primary end point(s) |
In order to assess the best timing of Pemetrexed-gemcitabine administration and the most appropriate interval between the two drug doses, monitoring of dCK and hENT induction by Pemetrexed will be performed |
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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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |