Clinical trial · Interventional
Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer
Randomized Phase II Study of Amrubicin as Single Agent or in Combination With Cisplatin Versus Etoposide-cisplatin as First-line Treatment in Patients With Extensive Stage SCLC (ES)
NCT00388960CI-TRIAL-00041755completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Amrubicin
- description
- Amrubicin 45mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
- interventionNames
- Drug: Amrubicin
- type
- EXPERIMENTAL
- label
- Amrubicin plus Cisplatin
- description
- 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.
- interventionNames
- Drug: Amrubicin
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- Cisplatin plus etoposide
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically/cytologically proven small cell lung cancer * Extensive disease * Measurable disease * World Health Organization (WHO) performance status 0-2 * Age 18 years or older * Normal baseline cardiac function * No prior systemic chemotherapy for small cell lung cancer * Adequate organ function including bone marrow, kidney, and liver * No history of interstitial lung disease or pulmonary fibrosis * No history of prior malignancy unless patient has been disease free for greater than 5 years, or the tumour was a non-melanoma skin cancer or in-situ carcinoma of the cervix * No pregnancy or breast feeding; patients of child-bearing potential must agree to use an appropriate method of contraception * Written informed consent before randomization Exclusion criteria: * Pre-existing peripheral neuropathy (greater than Grade 1, CTCAE version 3.0) * Uncontrolled or severe cardiovascular disease * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
References
Publications (2)
- BACKGROUNDO'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. PMID 21684151
- BACKGROUNDLiddell RP, Evans NS. May-Thurner syndrome. Vasc Med. 2018 Oct;23(5):493-496. doi: 10.1177/1358863X18794276. No abstract available. PMID 30187833