Status:
COMPLETED
Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer
Lead Sponsor:
Celgene
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00388960
Start Date
November 1 2006
End Date
December 1 2010
Last Update
November 19 2019
Active Locations (25)
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1
Algemeen Ziekenhuis Middelheim
Antwerp, Belgium, 2020
2
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
3
Universiteit Gent
Ghent, Belgium, 9000
4
U.Z. Gasthuisberg
Leuven, Belgium, 3000