Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer
This study has been completed.
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00388960
First received: October 13, 2006
Last updated: March 27, 2013
Last verified: April 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Small Cell Lung Cancer |
Drug: Amrubicin Drug: Cisplatin Drug: Etoposide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by Celgene Corporation:
Primary Outcome Measures:
- Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks) [ Time Frame: Until Disease Progression ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity [ Time Frame: Until 30 days after last protocol treatment ] [ Designated as safety issue: Yes ]
- Progression-free survival [ Time Frame: Until disease progression or death ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Until death ] [ Designated as safety issue: No ]
| Enrollment: | 99 |
| Study Start Date: | November 2006 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. 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. 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388960
Locations
| Belgium | |
| Algemeen Ziekenhuis Middelheim | |
| Antwerpen, Belgium, 2020 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, 2650 | |
| Universiteit Gent | |
| Gent, Belgium, 9000 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, 3000 | |
| Centre Hospitalier Regional de la Citadelle | |
| Liege, Belgium, 4000 | |
| Domaine Universitaire du Sart-Tilman | |
| Liege, Belgium, 1BE | |
| Clinique Sainte Elisabeth | |
| Namur, Belgium, 5000 | |
| Italy | |
| Instituto Nazionale per la Ricerca sul Cancro | |
| Genova, Italy, 16132 | |
| Universita Degli Studi Di Udine | |
| Udine, Italy, 33100 | |
| Netherlands | |
| Academisch Medisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| The Netherlands Cancer Institute Antoni Van Leeuwenhoekziekenhuis | |
| Amsterdam, Netherlands | |
| Medisch Spectrum Twente - Dept of Pulmonary Diseases | |
| Enschede, Netherlands, 7500 KA | |
| Leiden University Medical Centre | |
| Leiden, Netherlands, 2300RC | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands, 6202 | |
| Isala Kliniek | |
| Zwolle, Netherlands, 8001 | |
| Poland | |
| Medical University of Gdansk - Dept Radiotherapy | |
| Gdansk, Poland, 80211 | |
| United Kingdom | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Bebington, Merseyside, United Kingdom, CH684JY | |
| University of Dundee - Ninewells Hospital | |
| Dundee, Scotland, United Kingdom, D01 9SY | |
| Belfast City Hospital | |
| Belfast, United Kingdom, BT9 7AB | |
| Western General Hospital | |
| Edinburgh, United Kingdom, EH4 2XU | |
| Princess Royal Hospital | |
| Hull, United Kingdom, HU8 9HE | |
| Royal Marsden Hospital, London | |
| London, United Kingdom, SM2 5PT | |
| Christie Hospital | |
| Manchester, United Kingdom, M20 4BX | |
| Sir Bobby Robson Cancer Trials Research Centre | |
| Newcastle-Upon-Tyne, United Kingdom, NE4 6BE | |
| Royal Marsden Hospital Lung Unit | |
| Sutton, United Kingdom, (Surrey) SM2 5PT | |
Sponsors and Collaborators
Celgene Corporation
Investigators
| Principal Investigator: | Mary O'Brien, MD | Royal Marsden Hospital, London, UK |
More Information
No publications provided
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00388960 History of Changes |
| Obsolete Identifiers: | NCT00424073 |
| Other Study ID Numbers: | EORTC Protocol 08062, 2006-001956-11 |
| Study First Received: | October 13, 2006 |
| Last Updated: | March 27, 2013 |
| Health Authority: | European Union: European Medicines Agency |
Keywords provided by Celgene Corporation:
|
small cell lung cancer amrubicin |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Etoposide phosphate Amrubicin Cisplatin Etoposide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013