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

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT00388960

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Drug: Amrubicin Drug: Cisplatin Drug: Etoposide	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Amrubicin

Amrubicin 45mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression.

Drug: Amrubicin

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.

Experimental: Amrubicin plus 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.

Drug: Amrubicin

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.

Drug: Cisplatin

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.

Active Comparator: Cisplatin plus 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.

Drug: Cisplatin

Drug: 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 of each 21-day cycle until disease progression.

Outcome Measures

Primary Outcome Measures

Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks) [Until Disease Progression]

Secondary Outcome Measures

Toxicity [Until 30 days after last protocol treatment]
Progression-free survival [Until disease progression or death]
Overall survival [Until death]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Algemeen Ziekenhuis Middelheim	Antwerpen		Belgium	2020
2	Universitair Ziekenhuis Antwerpen	Edegem		Belgium	2650
3	Universiteit Gent	Gent		Belgium	9000
4	U.Z. Gasthuisberg	Leuven		Belgium	3000
5	Domaine Universitaire du Sart-Tilman	Liege		Belgium	1BE
6	Centre Hospitalier Regional de la Citadelle	Liege		Belgium	4000
7	Clinique Sainte Elisabeth	Namur		Belgium	5000
8	Instituto Nazionale per la Ricerca sul Cancro	Genova		Italy	16132
9	Universita Degli Studi Di Udine	Udine		Italy	33100
10	Academisch Medisch Centrum	Amsterdam		Netherlands	1105 AZ
11	The Netherlands Cancer Institute Antoni Van Leeuwenhoekziekenhuis	Amsterdam		Netherlands
12	Medisch Spectrum Twente - Dept of Pulmonary Diseases	Enschede		Netherlands	7500 KA
13	Leiden University Medical Centre	Leiden		Netherlands	2300RC
14	Academisch Ziekenhuis Maastricht	Maastricht		Netherlands	6202
15	Isala Kliniek	Zwolle		Netherlands	8001
16	Medical University of Gdansk - Dept Radiotherapy	Gdansk		Poland	80211
17	Clatterbridge Centre for Oncology NHS Trust	Bebington	Merseyside	United Kingdom	CH684JY
18	University of Dundee - Ninewells Hospital	Dundee	Scotland	United Kingdom	D01 9SY
19	Belfast City Hospital	Belfast		United Kingdom	BT9 7AB
20	Western General Hospital	Edinburgh		United Kingdom	EH4 2XU
21	Princess Royal Hospital	Hull		United Kingdom	HU8 9HE
22	Royal Marsden Hospital, London	London		United Kingdom	SM2 5PT
23	Christie Hospital	Manchester		United Kingdom	M20 4BX
24	Sir Bobby Robson Cancer Trials Research Centre	Newcastle-Upon-Tyne		United Kingdom	NE4 6BE
25	Royal Marsden Hospital Lung Unit	Sutton		United Kingdom	(Surrey) SM2 5PT