Clinical trial NCT00043927: Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults
Official title: An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small Cell Lung Cancer
Keywords: Chemotherapy-naive
Small Cell Lung Cancer
SCLC
Extensive disease
ED
topotecan
Hycamtin
oral
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2002-08-16
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.


Eligibility criteria: Inclusion Criteria:

* Written informed consent (patient's written understanding of and agreement to participate in this study).
* Patients with confirmed extensive small cell lung cancer (SCLC).
* No prior chemotherapy within 5 years of the diagnosis of SCLC.
* Presence of either measurable or non-measurable SCLC by X-ray or physical examination.
* At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient).
* At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting.
* Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion Criteria:

* Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids.
* Any active infection.
* Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk.
* Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC.
* Use of an investigational drug within 30 days before the first dose of study medication.
* Women who are pregnant or lactating.
* Patients of child-bearing potential who refuse to practice an adequate form of birth control.
* Patients with clinical evidence of any stomach or intestinal (GI) condition.
* Patients requiring treatment with the drug cyclosporin A.

Primary outcomes:
measure: Overall Survival
Secondary outcomes:
measure: response rates, response duration, time to progression, tolerability and patient-perceived disease status and well being for patients
Other outcomes:
Locations:
city: Hoover
country: United States
facility: GSK Clinical Trials Call Center
state: Alabama
city: Chula Vista
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Fountain Valley
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Greenbrae
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Poway
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Rancho Mirage
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Sacramento
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: San Diego
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: San Diego
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Soquel
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Vista
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Colorado Springs
country: United States
facility: GSK Clinical Trials Call Center
state: Colorado
city: Norwich
country: United States
facility: GSK Clinical Trials Call Center
state: Connecticut
city: Washington
country: United States
facility: GSK Clinical Trials Call Center
state: District of Columbia
city: Gainesville
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Miami Shores
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Ocala
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Pensacola
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Tarpon Springs
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Atlanta
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Atlanta
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Atlanta
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Atlanta
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Augusta
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Cummings
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Decatur
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Aurora
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Chicago
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Chicago
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Elk Grove Village
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Park Ridge
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Evansville
country: United States
facility: GSK Clinical Trials Call Center
state: Indiana
city: South Bend
country: United States
facility: GSK Clinical Trials Call Center
state: Indiana
city: New Orleans
country: United States
facility: GSK Clinical Trials Call Center
state: Louisiana
city: Shreveport
country: United States
facility: GSK Clinical Trials Call Center
state: Louisiana
city: Frederick
country: United States
facility: GSK Clinical Trials Call Center
state: Maryland
city: Pittsfield
country: United States
facility: GSK Clinical Trials Call Center
state: Massachusetts
city: Minneapolis
country: United States
facility: GSK Clinical Trials Call Center
state: Minnesota
city: St. Louis
country: United States
facility: GSK Clinical Trials Call Center
state: Missouri
city: Reno
country: United States
facility: GSK Clinical Trials Call Center
state: Nevada
city: Voorhees
country: United States
facility: GSK Clinical Trials Call Center
state: New Jersey
city: Albuquerque
country: United States
facility: GSK Clinical Trials Call Center
state: New Mexico
city: Albany
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: New York
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: New York
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Rochester
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Valhalla
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Bismarck
country: United States
facility: GSK Clinical Trials Call Center
state: North Dakota
city: Cleveland
country: United States
facility: GSK Clinical Trials Call Center
state: Ohio
city: Columbus
country: United States
facility: GSK Clinical Trials Call Center
state: Ohio
city: Portland
country: United States
facility: GSK Clinical Trials Call Center
state: Oregon
city: Lemoyne
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Limerick
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Columbia
country: United States
facility: GSK Clinical Trials Call Center
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Clinical Trials Call Center
state: South Carolina
city: Memphis
country: United States
facility: GSK Clinical Trials Call Center
state: Tennessee
city: Fort Worth
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Houston
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Abingdon
country: United States
facility: GSK Clinical Trials Call Center
state: Virginia
city: Norfolk
country: United States
facility: GSK Clinical Trials Call Center
state: Virginia
city: Olympia
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
city: Yakima
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
city: Morgantown
country: United States
facility: GSK Clinical Trials Call Center
state: West Virginia
city: Madison
country: United States
facility: GSK Clinical Trials Call Center
state: Wisconsin
city: Laramie
country: United States
facility: GSK Clinical Trials Call Center
state: Wyoming
city: Vienna
country: Austria
facility: GSK Clinical Trials Call Center
city: Vienna
country: Austria
facility: GSK Clinical Trials Call Center
city: Vienna
country: Austria
facility: GSK Clinical Trials Call Center
city: Charleroi
country: Belgium
facility: GSK Clinical Trials Call Center
city: Edegem
country: Belgium
facility: GSK Clinical Trials Call Center
city: Haine-Saint- Paul
country: Belgium
facility: GSK Clinical Trials Call Center
city: Leuven
country: Belgium
facility: GSK Clinical Trials Call Center
city: Liege
country: Belgium
facility: GSK Clinical Trials Call Center
city: Luxembourg
country: Belgium
facility: GSK Clinical Trials Call Center
city: Belo Horizonte
country: Brazil
facility: GSK Clinical Trials Call Center
city: Caxias do Sul
country: Brazil
facility: GSK Clinical Trials Call Center
city: Fortaleza
country: Brazil
facility: GSK Clinical Trials Call Center
city: Porto Alegre
country: Brazil
facility: GSK Clinical Trials Call Center
city: Porto Alegre
country: Brazil
facility: GSK Clinical Trials Call Center
city: Rio de Janeiro
country: Brazil
facility: GSK Clinical Trials Call Center
city: Salvador
country: Brazil
facility: GSK Clinical Trials Call Center
city: Sao Paulo
country: Brazil
facility: GSK Clinical Trials Call Center
city: Sao Paulo
country: Brazil
facility: GSK Clinical Trials Call Center
city: Bourgas
country: Bulgaria
facility: GSK Clinical Trials Call Center
city: Plovdiv
country: Bulgaria
facility: GSK Clinical Trials Call Center
city: Sofia
country: Bulgaria
facility: GSK Clinical Trials Call Center
city: Sofia
country: Bulgaria
facility: GSK Clinical Trials Call Center
city: Varna
country: Bulgaria
facility: GSK Clinical Trials Call Center
city: Calgary
country: Canada
facility: GSK Clinical Trials Call Center
state: Alberta
city: Edmonton
country: Canada
facility: GSK Clinical Trials Call Center
state: Alberta
city: Winnipeg
country: Canada
facility: GSK Clinical Trials Call Center
state: Manitoba
city: Sydney
country: Canada
facility: GSK Clinical Trials Call Center
state: Nova Scotia
city: Newmarket
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Oshawa
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Ottawa
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Peterborough
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Sault Sainte Marie
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Thunder Bay
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Toronto
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Weston
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Greenfield Park
country: Canada
facility: GSK Clinical Trials Call Center
state: Quebec
city: Montreal
country: Canada
facility: GSK Clinical Trials Call Center
state: Quebec
city: Montreal
country: Canada
facility: GSK Clinical Trials Call Center
state: Quebec
city: Montreal
country: Canada
facility: GSK Clinical Trials Call Center
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Clinical Trials Call Center
state: Quebec
city: Santiago
country: Chile
facility: GSK Clinical Trials Call Center
city: Beijing
country: China
facility: GSK Clinical Trials Call Center
city: Shanghai
country: China
facility: GSK Clinical Trials Call Center
city: Wangfujing
country: China
facility: GSK Clinical Trials Call Center
city: Xian
country: China
facility: GSK Clinical Trials Call Center
city: San Jose
country: Costa Rica
facility: GSK Clinical Trials Call Center
city: Hradec Kralove
country: Czech Republic
facility: GSK Clinical Trials Call Center
city: Olomouc
country: Czech Republic
facility: GSK Clinical Trials Call Center
city: Plzen
country: Czech Republic
facility: GSK Clinical Trials Call Center
city: Praha
country: Czech Republic
facility: GSK Clinical Trials Call Center
city: Praha
country: Czech Republic
facility: GSK Clinical Trials Call Center
city: Tallinn
country: Estonia
facility: GSK Clinical Trials Call Center
city: Helsinki
country: Finland
facility: GSK Clinical Trials Call Center
city: Kangasala
country: Finland
facility: GSK Clinical Trials Call Center
city: Oulu
country: Finland
facility: GSK Clinical Trials Call Center
city: Caen
country: France
facility: GSK Clinical Trials Call Center
city: Calais Cedex
country: France
facility: GSK Clinical Trials Call Center
city: Strasbourg
country: France
facility: GSK Clinical Trials Call Center
city: Vesoul
country: France
facility: GSK Clinical Trials Call Center
city: Heidelberg
country: Germany
facility: GSK Clinical Trials Call Center
state: Baden-Wurttemberg
city: Ebensfeld
country: Germany
facility: GSK Clinical Trials Call Center
state: Bayern
city: Gauting
country: Germany
facility: GSK Clinical Trials Call Center
state: Bayern
city: Grosshansdorf
country: Germany
facility: GSK Clinical Trials Call Center
city: Tegucigalpa
country: Honduras
facility: GSK Clinical Trials Call Center
city: Budapest
country: Hungary
facility: GSK Clinical Trials Call Center
city: Hungary
country: Hungary
facility: GSK Clinical Trials Call Center
city: Genova
country: Italy
facility: GSK Clinical Trials Call Center
state: Liguria
city: Lazio
country: Italy
facility: GSK Clinical Trials Call Center
city: Roma
country: Italy
facility: GSK Clinical Trials Call Center
city: Roma
country: Italy
facility: GSK Clinical Trials Call Center
city: Kingston
country: Jamaica
facility: GSK Clinical Trials Call Center
city: Seoul
country: Korea, Republic of
facility: GSK Clinical Trials Call Center
city: Seoul
country: Korea, Republic of
facility: GSK Clinical Trials Call Center
city: Kaunas
country: Lithuania
facility: GSK Clinical Trials Call Center
city: Vilnius
country: Lithuania
facility: GSK Clinical Trials Call Center
city: Chihuahua
country: Mexico
facility: GSK Clinical Trials Call Center
city: Guadalajara
country: Mexico
facility: GSK Clinical Trials Call Center
city: Guadalajara
country: Mexico
facility: GSK Clinical Trials Call Center
city: Mexico City
country: Mexico
facility: GSK Clinical Trials Call Center
city: Apeldoorn
country: Netherlands
facility: GSK Clinical Trials Call Center
city: Arnheim
country: Netherlands
facility: GSK Clinical Trials Call Center
city: Ede
country: Netherlands
facility: GSK Clinical Trials Call Center
city: Harderwijk
country: Netherlands
facility: GSK Clinical Trials Call Center
city: Nieuwegein
country: Netherlands
facility: GSK Clinical Trials Call Center
city: Hamilton
country: New Zealand
facility: GSK Clinical Trials Call Center
city: Wellington South
country: New Zealand
facility: GSK Clinical Trials Call Center
city: Oslo
country: Norway
facility: GSK Clinical Trials Call Center
city: Panama
country: Panama
facility: GSK Clinical Trials Call Center
city: Gdansk
country: Poland
facility: GSK Clinical Trials Call Center
city: Kielce
country: Poland
facility: GSK Clinical Trials Call Center
city: Ponce
country: Puerto Rico
facility: GSK Clinical Trials Call Center
city: Moscow Region
country: Russian Federation
facility: GSK Clinical Trials Call Center
city: Moscow
country: Russian Federation
facility: GSK Clinical Trials Call Center
city: Moscow
country: Russian Federation
facility: GSK Clinical Trials Call Center
city: Singapore
country: Singapore
facility: GSK Clinical Trials Call Center
city: Banska Bystrica
country: Slovakia
facility: GSK Clinical Trials Call Center
city: Bratislava
country: Slovakia
facility: GSK Clinical Trials Call Center
city: Kosice
country: Slovakia
facility: GSK Clinical Trials Call Center
city: Nitra
country: Slovakia
facility: GSK Clinical Trials Call Center
city: Johannesburg
country: South Africa
facility: GSK Clinical Trials Call Center
state: Gauteng
city: Lerida
country: Spain
facility: GSK Clinical Trials Call Center
city: Valencia
country: Spain
facility: GSK Clinical Trials Call Center
city: Taipei
country: Taiwan
facility: GSK Clinical Trials Call Center
city: Taipei
country: Taiwan
facility: GSK Clinical Trials Call Center
city: Aberdeen
country: United Kingdom
facility: GSK Clinical Trials Call Center
state: Aberdeenshire
city: Nottingham
country: United Kingdom
facility: GSK Clinical Trials Call Center
state: Nottinghamshire
city: Glasgow
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Leeds
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Leicester
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Poole
country: United Kingdom
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trial, MD
role: STUDY_DIRECTOR
References: