Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Amrubicin	Amrubicin	Amrubicin 45mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Amrubicin plus Cisplatin	Amrubicin	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.
Amrubicin plus Cisplatin	Cisplatin	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	Cisplatin	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.
Cisplatin plus etoposide	Etoposide	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.

Primary Outcome Measures

Name	Time	Method
Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)	Until Disease Progression

Secondary Outcome Measures

Name	Time	Method
Toxicity	Until 30 days after last protocol treatment
Overall survival	Until death
Progression-free survival	Until disease progression or death

Locations (25): Algemeen Ziekenhuis Middelheim
🇧🇪
Antwerpen, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪
Edegem, Belgium
Universiteit Gent
🇧🇪
Gent, Belgium
U.Z. Gasthuisberg
🇧🇪
Leuven, Belgium
Domaine Universitaire du Sart-Tilman
🇧🇪
Liege, Belgium
Centre Hospitalier Regional de la Citadelle
🇧🇪
Liege, Belgium
Clinique Sainte Elisabeth
🇧🇪
Namur, Belgium
Instituto Nazionale per la Ricerca sul Cancro
🇮🇹
Genova, Italy
Universita Degli Studi Di Udine
🇮🇹
Udine, Italy
Academisch Medisch Centrum
🇳🇱
Amsterdam, Netherlands
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Algemeen Ziekenhuis Middelheim
🇧🇪Antwerpen, Belgium