Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer

NCT00049998 | Completed Phase 3

• 1 other identifier: 104864-A/387
• Study Type: interventional
• Target: 760
• Locations: 30 countries
• Sites: 111

Brief Summary

The purpose of this study is to collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC).

Conditions

Non-Small-Cell Lung Cancer

Keywords

Nonsmall Cell Lung cancer; advanced; Second-line; topotecan; Hycamtin; oral; docetaxel

Outcome Measures

Primary Outcomes (1)

• One-year survival rate

Secondary Outcomes (1)

• overall survival, time to progression, response rate, response duration, time to response, improvement in quality of life and patient well-being, and qualitative and quantitative toxicities.

Interventions

topotecan DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Patients with advanced non-small cell lung cancer (NSCLC).
• Patients who have received one previous chemotherapy for NSCLC.
• Full recovery from previous chemotherapy.
• Presence of either measurable or non-measurable disease by radiologic study or physical examination.
• At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient).
• At least 24 hours since prior radiotherapy providing that marked bone marrow suppression is NOT expected. Patients who have received radiotherapy must have recovered from any reversible side effects (e.g. nausea and vomiting).
• Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

You may not qualify if:

• Symptoms of brain metastasis (cancer spreading to the brain), requiring treatment with steroids.
• Active infection.
• Severe medical problems other than the diagnosis of NSCLC, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
• Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC.
• Use of investigational drug within 30 days prior to the first dose of study medication.
• Women who are pregnant or lactating.
• Patients of child-bearing potential refusing to practice adequate birth control methods.
• Patients with conditions which might alter absorption of an oral drug.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (114)

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

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GSK Investigational Site

Bedford Park, South Australia, 5042, Australia

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Melbourne, Victoria, 3004, Australia

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Ringwood East, Victoria, 3128, Australia

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Innsbruck, A-6020, Austria

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Sankt Pölten, A-3100, Austria

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Vienna, A-1220, Austria

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Braasschaat, 2930, Belgium

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Brussels, 1200, Belgium

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Edegem, 2650, Belgium

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Liège, 4000, Belgium

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Sydney, Nova Scotia, B1P 1P3, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Thunder Bay, Ontario, P7B 6V4, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Toronto, Ontario, M6S 1B5, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Sainte-Foy, Quebec, G1V 4G5, Canada

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GSK Investigational Site

Xi'an, Shaanxi, 710061, China

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Beijing, 100036, China

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Shanghai, 200433, China

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Shanghai, China

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Tianjin, China

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Wangfujing, Beijing, 100730, China

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České Budějovice, 370 87, Czechia

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Kladno, 140 59, Czechia

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Prague, 14059, Czechia

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Herlev, Denmark

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Odense C, DK-5000, Denmark

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Helsinki, 00029, Finland

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Turku, 20520, Finland

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Caen, 14076, France

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Dijon, 21079, France

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Strasbourg, 67098, France

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Toulon Naval, 83800, France

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Vesoul, 70014, France

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Gauting, Bavaria, 82131, Germany

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Munich, Bavaria, 80336, Germany

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Regensburg, Bavaria, 93049, Germany

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Treuenbrietzen, Brandenburg, 14929, Germany

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Hamburg, Hamburg, 21075, Germany

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Leipzig, Saxony, 04207, Germany

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Berlin, State of Berlin, 14109, Germany

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Bad Berka, Thuringia, 99437, Germany

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Athens, 11526, Greece

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Heraklion, Crete, 71110, Greece

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Papagos, Athens, 15669, Greece

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Rio, Patras, 265 00, Greece

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Thessaloniki, 54007, Greece

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Budapest, 1529, Hungary

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Csorna, 9300, Hungary

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Miskolc, 3529, Hungary

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Ashkelon, 78306, Israel

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Beersheba, 84101, Israel

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Ramat Gan, 52621, Israel

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Tel Aviv, 64239, Israel

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Rome, Lazio, 00149, Italy

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Turin, Piedmont, 10126, Italy

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Sassari, Sardinia, 07100, Italy

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Perugia, Umbria, 06122, Italy

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Verona, Veneto, 37135, Italy

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Riga, LV 1002, Latvia

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Riga, LV 1079, Latvia

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Kaunas, LT-50009, Lithuania

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Vilnius, LT-08660, Lithuania

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's-Hertogenbosch, 5211 NL, Netherlands

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Delft, 2625 AD, Netherlands

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Groningen, 9721 SW, Netherlands

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Heerlen, 6419 PC, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Newtown, Wellington, 6002, New Zealand

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Quezon City, 1100, Philippines

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Poznan, 60-569, Poland

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Warsaw, 02-781, Poland

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Lisbon, 1769-166, Portugal

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Porto, 4200-319, Portugal

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Moscow, 115 478, Russia

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Moscow, 117 837, Russia

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Moscow, 129 128, Russia

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Nizhny Novgorod, 603 000, Russia

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Saint Petersburg, 198255, Russia

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Samara, 443066, Russia

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Singapore, 119074, Singapore

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Pretoria, Gauteng, South Africa

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Cape Town, Western Province, South Africa

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Port Elizabeth, 6001, South Africa

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Barakaldo (Vizcaya), 48903, Spain

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Jaén, 23007, Spain

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La Laguna (Santa Cruz de Tenerife), 38320, Spain

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Lleida, 25198, Spain

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Madrid, 28007, Spain

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Madrid, 28040, Spain

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Madrid, 28047, Spain

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Málaga, 29020, Spain

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Palma de Mallorca, 07014, Spain

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Pontevedra, 36002, Spain

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Valencia, 46009, Spain

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Zurich, CH-8091, Switzerland

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Taipei, 100, Taiwan

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Tau-Yuan County, 333, Taiwan

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Bangkok, 10400, Thailand

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Chiang Mai, 50200, Thailand

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Istanbul, 34280, Turkey (Türkiye)

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Izmir, 3510, Turkey (Türkiye)

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Kharkiv, Ukraine

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Luhansk, Ukraine

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Lviv, 79031, Ukraine

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Dundee, Forfarshire, DD1 9SY, United Kingdom

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Glasgow, Lanarkshire, G4 0SF, United Kingdom

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Leicester, Leicestershire, LE1 5WW, United Kingdom

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London, London, SE1 9RT, United Kingdom

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Nottingham, Nottinghamshire, United Kingdom

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GSK Investigational Site

Guildford, Surrey, GU2 7XX, United Kingdom

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 18, 2002
• First Posted: November 20, 2002
• Study Start: October 1, 2001
• Primary Completion: April 1, 2004
• Last Updated: March 4, 2013

Record last verified: 2013-03

Locations

GB (6); DK (2); ZA (3); PL (2); CN (6); CZ (3); TU (2); NZ (1); TH (2); GR (5); SG (1); DE (8); FI (2); PH (1); BE (4); IT (5); RU (6); ES (11); IL (4); CH (1); HU (3); LI (2); FR (5); PT (2); UA (3); AU (4); CA (8); NL (5); TW (2); LA (2)