| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001956-11 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to document the activity and safety of single agent amrubicin, amrubicin combined with cisplatin, and etoposide combined with cisplatin as first-line treatment in extensive disease small cell lung cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amrubicin | Experimental | Amrubicin 45mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression. |
|
| Amrubicin plus Cisplatin | Experimental | Amrubicin 40mg/m<2> IV days 1, 2, 3 plus cisplatin 60mg/m<2> IV day 1 of each 21-day cycle until disease progression. |
|
| Cisplatin plus etoposide | Active Comparator | Cisplatin 75mg/m<2> IV day 1 plus etoposide 100mg/m<2> IV day 1 and 200mg/m<2> orally days 2, 3 or etoposide 100mg/m<2> IV days 1, 2, 3 each 21-day cycle until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amrubicin | Drug | Amrubicin 45mg/m<2> IV days 1, 2 3 of each 21-day cycle until disease progression. Amrubicin 40mg/m<2> IV days 1, 2, 3 plus cisplatin 60mg/m<2> day 1 of each 21-day cycle until disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks) | Until Disease Progression |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Until 30 days after last protocol treatment | |
| Progression-free survival | Until disease progression or death | |
| Overall survival |
Not provided
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mary O'Brien, MD | Royal Marsden Hospital, London, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algemeen Ziekenhuis Middelheim | Antwerp | 2020 | Belgium | |||
| Universitair Ziekenhuis Antwerpen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21684151 | Background | O'Brien ME, Konopa K, Lorigan P, Bosquee L, Marshall E, Bustin F, Margerit S, Fink C, Stigt JA, Dingemans AM, Hasan B, Van Meerbeeck J, Baas P. Randomised phase II study of amrubicin as single agent or in combination with cisplatin versus cisplatin etoposide as first-line treatment in patients with extensive stage small cell lung cancer - EORTC 08062. Eur J Cancer. 2011 Oct;47(15):2322-30. doi: 10.1016/j.ejca.2011.05.020. Epub 2011 Jun 16. | |
| 30187833 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cisplatin | Drug | Amrubicin 40mg/m<2> IV days 1, 2, 3 plus Cisplatin 60mg/m<2> day 1 of each 21-day cycle until disease progression. Cisplatin 75mg/m<2> IV day 1 plus etoposide 100mg/m<2> IV day 1 and 200mg/m<2> orally days 2, 3 or etoposide 100mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression. |
|
| Etoposide | Drug | Cisplatin 75mg/m<2> IV day 1 plus etoposide 100mg/m<2> IV day 1 and 200mg/m<2> orally days 2, 3 or etoposide 100mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression. |
|
| Until death |
| Edegem |
| 2650 |
| Belgium |
| Universiteit Gent | Ghent | 9000 | Belgium |
| U.Z. Gasthuisberg | Leuven | 3000 | Belgium |
| Domaine Universitaire du Sart-Tilman | Liège | 1BE | Belgium |
| Centre Hospitalier Regional de la Citadelle | Liège | 4000 | Belgium |
| Clinique Sainte Elisabeth | Namur | 5000 | Belgium |
| Instituto Nazionale per la Ricerca sul Cancro | Genova | 16132 | Italy |
| Universita Degli Studi Di Udine | Udine | 33100 | Italy |
| Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| The Netherlands Cancer Institute Antoni Van Leeuwenhoekziekenhuis | Amsterdam | Netherlands |
| Medisch Spectrum Twente - Dept of Pulmonary Diseases | Enschede | 7500 KA | Netherlands |
| Leiden University Medical Centre | Leiden | 2300RC | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | 6202 | Netherlands |
| Isala Kliniek | Zwolle | 8001 | Netherlands |
| Medical University of Gdansk - Dept Radiotherapy | Gdansk | 80211 | Poland |
| Clatterbridge Centre for Oncology NHS Trust | Bebington | Merseyside | CH684JY | United Kingdom |
| University of Dundee - Ninewells Hospital | Dundee | Scotland | D01 9SY | United Kingdom |
| Belfast City Hospital | Belfast | BT9 7AB | United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Princess Royal Hospital | Hull | HU8 9HE | United Kingdom |
| Royal Marsden Hospital, London | London | SM2 5PT | United Kingdom |
| Christie Hospital | Manchester | M20 4BX | United Kingdom |
| Sir Bobby Robson Cancer Trials Research Centre | Newcastle upon Tyne | NE4 6BE | United Kingdom |
| Royal Marsden Hospital Lung Unit | Sutton | (Surrey) SM2 5PT | United Kingdom |
| Background |
| Liddell RP, Evans NS. May-Thurner syndrome. Vasc Med. 2018 Oct;23(5):493-496. doi: 10.1177/1358863X18794276. No abstract available. |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C055866 | amrubicin |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided