E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prospective randomized multi-center open label phase II study to determine the antitumoral activity and the feasibility of a combination therapy with Hycamtin/Carboplatin administered 5-days versus 3-days versus Topotecan monotherapy 5-days as second line treatment for patients with histological or cytological verified relapse or progression of extensive disease small cell lung cancer, documented later than 60 days after day 1 of the last cycle of first-line therapy. |
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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 | 10041068 |
E.1.2 | Term | Small cell lung cancer extensive stage |
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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 aim of this clinical trial is to determine the antitumoral activity and the feasibility of a combination therapy with Hycamtin/Carboplatin administered 5-days versus 3-days versus Topotecan monotherapy 5-days as second line treatment for patients with histological or cytological verified relapse or progression of extensive disease small cell lung cancer. Primary endpoint is the disease control rate (DCR). The DCR consists of all patients with complete response, partial response and stable disease. |
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E.2.2 | Secondary objectives of the trial |
• Overall survival • Quality of life • Remission rate • Time to progression • Tolerance to study drugs |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Pre-treated histologically confirmed small cell lung cancer (cytological diagnoses is permitted only in definitely and doubtless cases) • Relapse or progression of small cell lung cancer at least 60 days after day 1 of the last cycle of first-line therapy.
• ECOG Performance Status < 2
• Life expectancy not less than 2 month
• No contraindication against any study medication used in this study
• No more than one previous chemotherapy with a minimum of 4 and a maximum of 6 cycles. The previous chemotherapy had to be platin-based.
• Age ≥ 18 years
• Extensive disease at the time of relapse with indication to systemic chemotherapy
• Adequate haematological parameters:
- Leukocytes: >3.500 µl - Neutrophiles: >1.500 µl - Platelets: >100.000 µl - Hemoglobin >9 g/dl (to reach a Hb of 9 g/dl it is permittet to perform a transfusion of pRBCs or to apply Erythropoietin (EPO)
• Adequate hepatic laboratory parameters:
- Bilirubin : <1,5 x ULN - Alk. Phosphatase: <3,0 x ULN
• Adequate renal laboratory parameters:
- Creatinin-Clearance > 60 ml/min
• Provision of informed consent according to local regulatory requirements prior to any protocol specific treatment
• Measurable lesion according to RECIST-Criteria
• Negative pregnancy test for women of childbearing potential unless they are postmenopausal at baseline. (Postmenopausal women must have been amenorrheic at least for 12 months to be considered of non childbearing potential)
• Women of child bearing potential must be willing to use an acceptable method to avoid pregnancy at least one month before study start. Examples: oral contraceptives (sole application of oral contraceptives is not sufficient), diaphragm pessary, intrauterine device (spiral), condom plus diaphragm pessary plus spermicide.
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E.4 | Principal exclusion criteria |
• Patients without a previous chemotherapy
• More than one previous chemotherapy
• Patients with a previous radiotherapy (>25% Irradiation of bone marrow) within 6 weeks prior to study start
• Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of non-melanomatous skin cancer or cervical carcinoma of the cervix after curative therapy.
• Pregnancy or lactation period or lack of effective contraception
• Active infections prior to study start
• Respiratory insufficiency
• Cardiac insufficiency and NYHA III und IV
• Known active Hepatitis B or Hepatitis C or HIV-Infection
• Known hypersensitivity to any of the study drugs
• Life expectancy less than 2 month
• Patients with symptoms of CNS metastases or leptomeningeal metastasis receiving more than 12 mg/day dexamethasone
• History of a mental disease or condition such as to interfere with the patient's ability to understand the requirements of the study protocol
• Patients with any clinically significant disease that is in the opinion of the investigator likely to put the patient at risk or to interfere with the evaluation of the patient's safety and of the study outcome.
• Concurrent participation in an other clinical trial
• Participation in another clinical trial within the last 4 weeks
• Male trial subjects not willing to use an acceptable method to avoid pregnancy of his wife/partner
• Alcohol an drug abuse |
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E.5 End points |
E.5.1 | Primary end point(s) |
The aim of this clinical trial is to determine the antitumoral activity and the feasibility of a combination therapy with Hycamtin/Carboplatin administered 5-days versus 3-days versus Topotecan monotherapy 5-days as second line treatment for patients with histological or cytological verified relapse or progression of extensive disease small cell lung cancer. Primary endpoint is the disease control rate (DCR). The DCR consists of all patients with complete response, partial response and stable disease. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 50 |
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 | Yes |
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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |