Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults

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.

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.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: topotecan/cisplatin; Drug: etoposide/cisplatin

• Study Type: Interventional
• Enrollment: 760
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A-1090
    • GSK Clinical Trials Call Center
  • Vienna, Austria, A-1130
    • GSK Clinical Trials Call Center
  • Vienna, Austria, A-1140
    • GSK Clinical Trials Call Center
• Belgium
  • Charleroi, Belgium, 6000
    • GSK Clinical Trials Call Center
  • Edegem, Belgium, 2650
    • GSK Clinical Trials Call Center
  • Haine-Saint- Paul, Belgium, 7100
    • GSK Clinical Trials Call Center
  • Leuven, Belgium, 3000
    • GSK Clinical Trials Call Center
  • Liege, Belgium, 4000
    • GSK Clinical Trials Call Center
  • Luxembourg, Belgium, 1210
    • GSK Clinical Trials Call Center
• Brazil
  • Belo Horizonte, Brazil, 30140-083
    • GSK Clinical Trials Call Center
  • Caxias do Sul, Brazil, 95010-060
    • GSK Clinical Trials Call Center
  • Fortaleza, Brazil, 60430-230
    • GSK Clinical Trials Call Center
  • Porto Alegre, Brazil, 90020-090
    • GSK Clinical Trials Call Center
  • Porto Alegre, Brazil, 90035-003
    • GSK Clinical Trials Call Center
  • Rio de Janeiro, Brazil, 20230-130
    • GSK Clinical Trials Call Center
  • Salvador, Brazil, 41920-000
    • GSK Clinical Trials Call Center
  • Sao Paulo, Brazil, 04023-062
    • GSK Clinical Trials Call Center
  • Sao Paulo, Brazil, 05403-900
    • GSK Clinical Trials Call Center
• Bulgaria
  • Bourgas, Bulgaria, 8000
    • GSK Clinical Trials Call Center
  • Plovdiv, Bulgaria, 4000
    • GSK Clinical Trials Call Center
  • Sofia, Bulgaria, 1000/1527
    • GSK Clinical Trials Call Center
  • Sofia, Bulgaria, 1156
    • GSK Clinical Trials Call Center
  • Varna, Bulgaria, 9010
    • GSK Clinical Trials Call Center
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • GSK Clinical Trials Call Center
    • Edmonton, Alberta, Canada, T6G 1E2
      • GSK Clinical Trials Call Center
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • GSK Clinical Trials Call Center
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1P 1P3
      • GSK Clinical Trials Call Center
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P9
      • GSK Clinical Trials Call Center
    • Oshawa, Ontario, Canada, L1G 2B9
      • GSK Clinical Trials Call Center
    • Ottawa, Ontario, Canada, K1H 1C4
      • GSK Clinical Trials Call Center
    • Peterborough, Ontario, Canada, K9H 7B6
      • GSK Clinical Trials Call Center
    • Sault Sainte Marie, Ontario, Canada, P6B 1Y5
      • GSK Clinical Trials Call Center
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • GSK Clinical Trials Call Center
    • Toronto, Ontario, Canada, M5G 2M9
      • GSK Clinical Trials Call Center
    • Weston, Ontario, Canada, M9N 1N8
      • GSK Clinical Trials Call Center
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • GSK Clinical Trials Call Center
    • Montreal, Quebec, Canada, H1T 2M4
      • GSK Clinical Trials Call Center
    • Montreal, Quebec, Canada, H2L 4M1
      • GSK Clinical Trials Call Center
    • Montreal, Quebec, Canada, H3T 1E2
      • GSK Clinical Trials Call Center
    • Sainte-Foy, Quebec, Canada, G1V 4G5
      • GSK Clinical Trials Call Center
• Chile
  • Santiago, Chile
    • GSK Clinical Trials Call Center
• China
  • Beijing, China, 100036
    • GSK Clinical Trials Call Center
  • Shanghai, China, 200433
    • GSK Clinical Trials Call Center
  • Wangfujing, China, 100730
    • GSK Clinical Trials Call Center
  • Xian, China, 710061
    • GSK Clinical Trials Call Center
• Costa Rica
  • San Jose, Costa Rica
    • GSK Clinical Trials Call Center
• Czech Republic
  • Hradec Kralove, Czech Republic, 500 05
    • GSK Clinical Trials Call Center
  • Olomouc, Czech Republic, 775 25
    • GSK Clinical Trials Call Center
  • Plzen, Czech Republic, 305 99
    • GSK Clinical Trials Call Center
  • Praha, Czech Republic, 121 00
    • GSK Clinical Trials Call Center
  • Praha, Czech Republic, 150 05
    • GSK Clinical Trials Call Center
• Estonia
  • Tallinn, Estonia, 11619
    • GSK Clinical Trials Call Center
• Finland
  • Helsinki, Finland, 29
    • GSK Clinical Trials Call Center
  • Kangasala, Finland, 36280
    • GSK Clinical Trials Call Center
  • Oulu, Finland, 90029
    • GSK Clinical Trials Call Center
• France
  • Caen, France, 14076
    • GSK Clinical Trials Call Center
  • Calais Cedex, France, 62107
    • GSK Clinical Trials Call Center
  • Strasbourg, France, 67091
    • GSK Clinical Trials Call Center
  • Vesoul, France, 70014
    • GSK Clinical Trials Call Center
• Germany
  • Grosshansdorf, Germany, 22927
    • GSK Clinical Trials Call Center
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69126
      • GSK Clinical Trials Call Center
  • Bayern
    • Ebensfeld, Bayern, Germany, 96250
      • GSK Clinical Trials Call Center
    • Gauting, Bayern, Germany, 82131
      • GSK Clinical Trials Call Center
• Honduras
  • Tegucigalpa, Honduras
    • GSK Clinical Trials Call Center
• Hungary
  • Budapest, Hungary, 1529
    • GSK Clinical Trials Call Center
  • Hungary, Hungary, 8900
    • GSK Clinical Trials Call Center
• Italy
  • Lazio, Italy, 149
    • GSK Clinical Trials Call Center
  • Roma, Italy, 149
    • GSK Clinical Trials Call Center
  • Roma, Italy, 184
    • GSK Clinical Trials Call Center
  • Liguria
    • Genova, Liguria, Italy, 16132
      • GSK Clinical Trials Call Center
• Jamaica
  • Kingston, Jamaica
    • GSK Clinical Trials Call Center
• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • GSK Clinical Trials Call Center
  • Seoul, Korea, Republic of, 120-752
    • GSK Clinical Trials Call Center
• Lithuania
  • Kaunas, Lithuania, LT-45434
    • GSK Clinical Trials Call Center
  • Vilnius, Lithuania, LT-08660
    • GSK Clinical Trials Call Center
• Mexico
  • Chihuahua, Mexico, 31000
    • GSK Clinical Trials Call Center
  • Guadalajara, Mexico, 44280
    • GSK Clinical Trials Call Center
  • Guadalajara, Mexico, 45170
    • GSK Clinical Trials Call Center
  • Mexico City, Mexico, 14000
    • GSK Clinical Trials Call Center
• Netherlands
  • Apeldoorn, Netherlands, 7334 DZ
    • GSK Clinical Trials Call Center
  • Arnheim, Netherlands, 6815 AD
    • GSK Clinical Trials Call Center
  • Ede, Netherlands, 6716 RP
    • GSK Clinical Trials Call Center
  • Harderwijk, Netherlands, 3844 DG
    • GSK Clinical Trials Call Center
  • Nieuwegein, Netherlands, 3435 CM
    • GSK Clinical Trials Call Center
• New Zealand
  • Hamilton, New Zealand, 2001
    • GSK Clinical Trials Call Center
  • Wellington South, New Zealand, 6002
    • GSK Clinical Trials Call Center
• Norway
  • Oslo, Norway, 407
    • GSK Clinical Trials Call Center
• Panama
  • Panama, Panama
    • GSK Clinical Trials Call Center
• Poland
  • Gdansk, Poland, 80-211
    • GSK Clinical Trials Call Center
  • Kielce, Poland, 25-640
    • GSK Clinical Trials Call Center
• Puerto Rico
  • Ponce, Puerto Rico, 716
    • GSK Clinical Trials Call Center
• Russian Federation
  • Moscow, Russian Federation, 107 055
    • GSK Clinical Trials Call Center
  • Moscow, Russian Federation, 115 478
    • GSK Clinical Trials Call Center
  • Moscow Region, Russian Federation, 143 423
    • GSK Clinical Trials Call Center
• Singapore
  • Singapore, Singapore, 119074
    • GSK Clinical Trials Call Center
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • GSK Clinical Trials Call Center
  • Bratislava, Slovakia, 825 56
    • GSK Clinical Trials Call Center
  • Kosice, Slovakia, 041 09
    • GSK Clinical Trials Call Center
  • Nitra, Slovakia, 949 88
    • GSK Clinical Trials Call Center
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • GSK Clinical Trials Call Center
• Spain
  • Lerida, Spain, 25198
    • GSK Clinical Trials Call Center
  • Valencia, Spain, 46009
    • GSK Clinical Trials Call Center
• Taiwan
  • Taipei, Taiwan, 100
    • GSK Clinical Trials Call Center
  • Taipei, Taiwan, 105
    • GSK Clinical Trials Call Center
• United Kingdom
  • Glasgow, United Kingdom, G4 0SF
    • GSK Clinical Trials Call Center
  • Leeds, United Kingdom, LS16 6QB
    • GSK Clinical Trials Call Center
  • Leicester, United Kingdom, LE1 5WW
    • GSK Clinical Trials Call Center
  • Poole, United Kingdom, BH15 2JB
    • GSK Clinical Trials Call Center
  • Aberdeenshire
    • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
      • GSK Clinical Trials Call Center
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • GSK Clinical Trials Call Center
• United States
  • Alabama
    • Hoover, Alabama, United States, 35216
      • GSK Clinical Trials Call Center
  • California
    • Chula Vista, California, United States, 91911
      • GSK Clinical Trials Call Center
    • Fountain Valley, California, United States, 92708
      • GSK Clinical Trials Call Center
    • Greenbrae, California, United States, 94904
      • GSK Clinical Trials Call Center
    • Poway, California, United States, 92064
      • GSK Clinical Trials Call Center
    • Rancho Mirage, California, United States, 92270
      • GSK Clinical Trials Call Center
    • Sacramento, California, United States, 95816-5616
      • GSK Clinical Trials Call Center
    • San Diego, California, United States, 92102-8421
      • GSK Clinical Trials Call Center
    • San Diego, California, United States, 92121
      • GSK Clinical Trials Call Center
    • Soquel, California, United States, 95073
      • GSK Clinical Trials Call Center
    • Vista, California, United States, 92083
      • GSK Clinical Trials Call Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • GSK Clinical Trials Call Center
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • GSK Clinical Trials Call Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20307-5001
      • GSK Clinical Trials Call Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • GSK Clinical Trials Call Center
    • Miami Shores, Florida, United States, 33138
      • GSK Clinical Trials Call Center
    • Ocala, Florida, United States, 34471
      • GSK Clinical Trials Call Center
    • Pensacola, Florida, United States, 32501
      • GSK Clinical Trials Call Center
    • Tarpon Springs, Florida, United States, 34689
      • GSK Clinical Trials Call Center
  • Georgia
    • Atlanta, Georgia, United States, 30030
      • GSK Clinical Trials Call Center
    • Atlanta, Georgia, United States, 30308
      • GSK Clinical Trials Call Center
    • Atlanta, Georgia, United States, 30328
      • GSK Clinical Trials Call Center
    • Atlanta, Georgia, United States, 30335
      • GSK Clinical Trials Call Center
    • Augusta, Georgia, United States, 30912
      • GSK Clinical Trials Call Center
    • Cummings, Georgia, United States, 30040
      • GSK Clinical Trials Call Center
    • Decatur, Georgia, United States, 30033
      • GSK Clinical Trials Call Center
  • Illinois
    • Aurora, Illinois, United States, 60506
      • GSK Clinical Trials Call Center
    • Chicago, Illinois, United States, 60612
      • GSK Clinical Trials Call Center
    • Chicago, Illinois, United States, 60637-1470
      • GSK Clinical Trials Call Center
    • Elk Grove Village, Illinois, United States, 60007
      • GSK Clinical Trials Call Center
    • Park Ridge, Illinois, United States, 60068
      • GSK Clinical Trials Call Center
  • Indiana
    • Evansville, Indiana, United States, 47713
      • GSK Clinical Trials Call Center
    • South Bend, Indiana, United States, 46601
      • GSK Clinical Trials Call Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • GSK Clinical Trials Call Center
    • Shreveport, Louisiana, United States, 71103
      • GSK Clinical Trials Call Center
  • Maryland
    • Frederick, Maryland, United States, 21701
      • GSK Clinical Trials Call Center
  • Massachusetts
    • Pittsfield, Massachusetts, United States, 01201
      • GSK Clinical Trials Call Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • GSK Clinical Trials Call Center
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • GSK Clinical Trials Call Center
  • Nevada
    • Reno, Nevada, United States, 89502
      • GSK Clinical Trials Call Center
  • New Jersey
    • Voorhees, New Jersey, United States, 08043
      • GSK Clinical Trials Call Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • GSK Clinical Trials Call Center
  • New York
    • Albany, New York, United States, 12208
      • GSK Clinical Trials Call Center
    • New York, New York, United States, 10021
      • GSK Clinical Trials Call Center
    • New York, New York, United States, 10032
      • GSK Clinical Trials Call Center
    • Rochester, New York, United States, 14623
      • GSK Clinical Trials Call Center
    • Valhalla, New York, United States, 10595
      • GSK Clinical Trials Call Center
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • GSK Clinical Trials Call Center
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • GSK Clinical Trials Call Center
    • Columbus, Ohio, United States, 43222
      • GSK Clinical Trials Call Center
  • Oregon
    • Portland, Oregon, United States, 97232-2099
      • GSK Clinical Trials Call Center
  • Pennsylvania
    • Lemoyne, Pennsylvania, United States, 17043
      • GSK Clinical Trials Call Center
    • Limerick, Pennsylvania, United States, 19468
      • GSK Clinical Trials Call Center
    • Philadelphia, Pennsylvania, United States, 19140
      • GSK Clinical Trials Call Center
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • GSK Clinical Trials Call Center
    • Spartanburg, South Carolina, United States, 29303
      • GSK Clinical Trials Call Center
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • GSK Clinical Trials Call Center
  • Texas
    • Fort Worth, Texas, United States, 76104
      • GSK Clinical Trials Call Center
    • Houston, Texas, United States, 77060
      • GSK Clinical Trials Call Center
  • Virginia
    • Abingdon, Virginia, United States, 24211
      • GSK Clinical Trials Call Center
    • Norfolk, Virginia, United States, 23502
      • GSK Clinical Trials Call Center
  • Washington
    • Olympia, Washington, United States, 98506
      • GSK Clinical Trials Call Center
    • Yakima, Washington, United States, 98902
      • GSK Clinical Trials Call Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • GSK Clinical Trials Call Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • GSK Clinical Trials Call Center
  • Wyoming
    • Laramie, Wyoming, United States, 82070
      • GSK Clinical Trials Call Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall Survival

Secondary Outcome Measures

Outcome Measure
response rates, response duration, time to progression, tolerability and patient-perceived disease status and well being for patients

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trial, MD, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: April 1, 2001
• Primary Completion (Actual): January 1, 2004

Study Registration Dates

• First Submitted: August 14, 2002
• First Submitted That Met QC Criteria: August 15, 2002
• First Posted (Estimate): August 16, 2002

Study Record Updates

• Last Update Posted (Estimate): August 21, 2013
• Last Update Submitted That Met QC Criteria: August 20, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: ED; Hycamtin; oral; Small Cell Lung Cancer; topotecan; SCLC; Chemotherapy-naive; Extensive disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Etoposide; Cisplatin; Topotecan
• Other Study ID Numbers: 104864-A/389