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

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small Cell Lung Cancer

Intervention: Amrubicin (Drug); Cisplatin (Drug); Etoposide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Celgene Corporation

Official(s) and/or principal investigator(s):
Mary O'Brien, MD, Principal Investigator, Affiliation: Royal Marsden Hospital, London, UK

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.

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)

Secondary outcome:

Toxicity

Progression-free survival

Overall survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Algemeen Ziekenhuis Middelheim, Antwerpen 2020, Belgium

Universitair Ziekenhuis Antwerpen, Edegem 2650, Belgium

Universiteit Gent, Gent 9000, Belgium

U.Z. Gasthuisberg, Leuven 3000, Belgium

Centre Hospitalier Regional de la Citadelle, Liege 4000, Belgium

Domaine Universitaire du Sart-Tilman, Liege 1BE, Belgium

Clinique Sainte Elisabeth, Namur 5000, Belgium

Instituto Nazionale per la Ricerca sul Cancro, Genova 16132, Italy

Universita Degli Studi Di Udine, Udine 33100, Italy

Academisch Medisch Centrum, Amsterdam 1105 AZ, Netherlands

The Netherlands Cancer Institute Antoni Van Leeuwenhoekziekenhuis, Amsterdam, Netherlands

Medisch Spectrum Twente - Dept of Pulmonary Diseases, Enschede 7500 KA, Netherlands

Leiden University Medical Centre, Leiden 2300RC, Netherlands

Academisch Ziekenhuis Maastricht, Maastricht 6202, Netherlands

Isala Kliniek, Zwolle 8001, Netherlands

Medical University of Gdansk - Dept Radiotherapy, Gdansk 80211, Poland

Belfast City Hospital, Belfast BT9 7AB, United Kingdom

Western General Hospital, Edinburgh EH4 2XU, United Kingdom

Princess Royal Hospital, Hull HU8 9HE, United Kingdom

Royal Marsden Hospital, London, London SM2 5PT, United Kingdom

Christie Hospital, Manchester M20 4BX, United Kingdom

Sir Bobby Robson Cancer Trials Research Centre, Newcastle-Upon-Tyne NE4 6BE, United Kingdom

Royal Marsden Hospital Lung Unit, Sutton (Surrey) SM2 5PT, United Kingdom

Clatterbridge Centre for Oncology NHS Trust, Bebington, Merseyside CH684JY, United Kingdom

University of Dundee - Ninewells Hospital, Dundee, Scotland D01 9SY, United Kingdom

Additional Information

Starting date: November 2006
Last updated: March 27, 2013

Page last updated: August 23, 2015

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