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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Amrubicin
* Drug: Cisplatin
* Drug: Etoposide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amrubicin<br>Amrubicin 45mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression. | Drug: Amrubicin<br>* 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.<br>|
| Experimental: Amrubicin plus Cisplatin<br>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. | Drug: Amrubicin<br>* 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.<br>Drug: Cisplatin<br>* 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.<br>|
| Active Comparator: Cisplatin plus etoposide<br>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. | Drug: Cisplatin<br>* 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.<br>Drug: Etoposide<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks) |  | Until Disease Progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | Until 30 days after last protocol treatment | 
| Progression-free survival |  | Until disease progression or death | 
| Overall survival |  | Until death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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small cell lung cancer, amrubicin