TORCH: A Study of Tarceva or Chemotherapy for the Treatment of Advanced Non Small Cell Lung Cancer

NCT00349219 | Completed Phase 3 DMC

• 2 other identifiers: TORCH2005-005968-90
• Study Type: interventional
• Target: 760
• Locations: 2 countries
• Sites: 73

Brief Summary

The purpose of this study is to compare first-line erlotinib followed at progression by second-line chemotherapy vs. first-line chemotherapy followed at progression by second-line erlotinib in the treatment of Advanced Non Small Cell Lung Cancer (NSCLC).

Conditions

Advanced Non-Small Cell Lung Cancer

Keywords

first-line; second-line; targeted therapy

Outcome Measures

Primary Outcomes (2)

• overall survival

  one year

• progression free rate of first-line treatment with erlotinib

  after 9 weeks of treatment

Secondary Outcomes (6)

• toxicity

  every 3 weeks during treatment, and every 3 months thereafter

• progression-free survival

  one year

• quality of life during the first-line therapy

  every 3 weeks during first-line therapy

• prognostic biologic indicators

  end of study

• resource utilization

  every 6 weeks during first-line therapy

Study Arms (2)

1

EXPERIMENTAL

erlotinib followed at progression by gemcitabine and cisplatin

Drug: erlotinib; Drug: cisplatin; Drug: gemcitabine

2

ACTIVE COMPARATOR

cisplatin and gemcitabine chemotherapy for 6 cycles, followed at progression by erlotinib

Drug: cisplatin; Drug: gemcitabine; Drug: erlotinib

Interventions

erlotinib DRUG

erlotinib 150 mg taken orally daily until disease progression

Also known as: Tarceva

1

cisplatin DRUG

cisplatin 80 mg/m2 IV day 1 every 3 weeks given in second-line therapy

1

gemcitabine DRUG

gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks, given in second-line

1

Eligibility Criteria

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

You may qualify if:

• Diagnosis of cytologically or histologically confirmed non-small cell lung cancer
• Metastatic (stage IV) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes or with pleural effusion).
• Both patients at first diagnosis or those with disease recurrence after former surgery are eligible.
• At least one target or non-target lesion according to RECIST criteria
• Male or female \> 18 years of age (Italy upper age limit 70 years)
• ECOG PS 0 or 1
• Life expectancy of \> 3 months
• Neutrophils \> 1,500 mm3, platelets \> 100,000 mm3, and hemoglobin \> 9 g/dL
• Bilirubin level either normal or \< 1.5 x ULN
• AST (SGOT) and ALT (SGPT) \< 2.5 x ULN (\< 5 x ULN if liver metastasis are present)
• Serum creatinine \< 1.5 x ULN
• Effective contraception for both, male and female patients if the risk of conception exists
• Signed written informed consent

You may not qualify if:

• Prior exposure to agents directed at the HER axis (e.g. gefitinib, cetuximab, trastuzumab).
• Prior chemotherapy or therapy with systemic anti-neoplastic therapy (e.g., monoclonal antibody therapy) for advanced disease. Prior surgery and/or localised irradiation is permitted. Prior neoadjuvant chemotherapy for operable disease or adjuvant chemotherapy is permitted if it did not contain gemcitabine and if at least 1 year elapsed from the end of chemotherapy and the date of relapse.
• Any unstable systemic disease (including active infections, significant cardiovascular disease or myocardial infarction within the previous year, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medications or render the patient at high risk from treatment complications.
• Any other malignancies within past 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA).
• Patients are excluded if they have brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression without evidence of stable disease (clinically stable imaging) for at least 2 months will also cause patients to be excluded. Patients with asymptomatic CNS metastases and not requiring steroids to control symptoms can be included, even if on anti-seizure medications.
• HIV positive patients
• Any inflammatory changes of the surface of the eye at baseline
• Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
• Nursing and/or pregnant females
• Known or suspected hypersensitivity to any of the study drugs.

Sponsors & Collaborators

• National Cancer Institute, Naples: lead
• San Giuseppe Moscati Hospital: collaborator
• Princess Margaret Hospital, Canada: collaborator
• University of Alberta: collaborator
• University of Campania Luigi Vanvitelli: collaborator

Study Sites (73)

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Location

University of Alberta Cross Cancer Institute

Edmonton, Alberta, Canada

Location

BC Cancer Agency Vancouver Island

Victoria, British Columbia, Canada

Location

Cancer Care Mannitoba

Winnipeg, Manitoba, Canada

Location

QE II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Hôpital Régional de Sudbury Regional Hospital

Greater Sudbury, Ontario, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Location

Kingston Regional Cancer Centre

Kingston, Ontario, Canada

Location

Credit Valley Hospital

Mississauga, Ontario, Canada

Location

Durham Regional Cancer Centre

Oshawa, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, Canada

Location

Windsor Regional Cancer Centre

Windsor, Ontario, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Location

McGill University Cancer Centre

Montreal, Canada

Location

ASL Viterbo Ospedale

Belcolle, (vt), Italy

Location

Azienda Sanitaria S. Giuseppe Moscati

Monteforte Irpino, AV, Italy

Location

Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale

Bari, BA, 70126, Italy

Location

Università di Chieti, Cattedra di Oncologia Medica

Chieti, CH, Italy

Location

Humanitas Centro Catanese di Oncologia

Catania, CT, Italy

Location

Ospedale di Gaeta

Gaeta, LT, 04024, Italy

Location

Ospedale S. Vincenzo di Taormina

Taormina, ME, Italy

Location

Policlinico Universitario P. Giaccone

Palermo, PA, 90100, Italy

Location

Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico

Palermo, PA, 90146, Italy

Location

Azienda Ospedaliera V. Cervello

Palermo, PA, Italy

Location

Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia

Pordenone, PN, 33170, Italy

Location

Ospedale di Prato

Prato, PO, 59100, Italy

Location

Ospedale Civile di Faenza, Divisione di Oncologia Medica

Faenza, RA, 48018, Italy

Location

Istituto Regina Elena, Divisione di Oncologia Medica

Roma, Roma, 00144, Italy

Location

Ospedale S. Luca

Vallo della Lucania, SA, Italy

Location

Ospedale San Lazzaro

Alba, Italy

Location

Ospedale Cardinal Massaia

Asti, Italy

Location

C.R.O. Istituto Nazionale Tumori

Aviano, Italy

Location

Azienda Ospedaliera G. Rummo, Unità Operativa di Oncologia Medica

Benevento, Italy

Location

Ospedale Senatore Antonio Perrino

Brindisi, Italy

Location

Ospedale A. Cardarelli, divisione Medicina Interna

Campobasso, Italy

Location

Ospedale Ramazzini, Day Hospital Oncologico

Carpi, Italy

Location

A.O. Ospedale Mater Domini, Oncoematologia Università Magna Grecia

Catanzaro, Italy

Location

Ospedale Mariano Santo, U.O. di Oncologia Medica

Cosenza, Italy

Location

Ospedale S. Corce

Fano, Italy

Location

Azienda Ospedaliera Careggi

Florence, Italy

Location

Azienda Ospedaliera Morgagni Pierantoni

Forlì, Italy

Location

Ospedale Umberto I, U.O. di Oncologia Medica

Frosinone, Italy

Location

Ospedale S. Martino

Genova, Italy

Location

Ospedale Villa Scassi

Genova, Italy

Location

Ospedale S. Maria Goretti

Latina, Italy

Location

A.O. Vito Fazzi

Lecce, Italy

Location

Ospedale C. Poma

Mantova, Italy

Location

Policlinico Universitario G. Martino

Messina, Italy

Location

Casa di Cura IGEA

Milan, Italy

Location

Niguarda Ca' Granda

Milan, Italy

Location

Ospedale L. Sacco, GISCAD Oncologia, Polo Universitario

Milan, Italy

Location

Buon Consiglio Fatebenefratelli

Napoli, Italy

Location

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

Napoli, Italy

Location

Ospedale Cardarelli

Napoli, Italy

Location

Second University of Naples

Napoli, Italy

Location

Università Federico II, Cattedra di Oncologia Medica

Napoli, Italy

Location

Divisione di Oncologia Medica, U.S.L.L. 13

Noale, Italy

Location

Ospedale Civile Umbero I

Nocera Inferiore, Italy

Location

Ospedale Civile di Nola, Reparto di Oncologia

Nola, Italy

Location

Istituto Oncologico Veneto

Padua, Italy

Location

Fondazione Salvatore Maugeri

Pavia, Italy

Location

Ospedale S. Salvatore

Pesaro, Italy

Location

Ospedale Guglielmo da Saliceto

Piacenza, Italy

Location

Azienda Ospedaliera S. Carol

Potenza, Italy

Location

Ospedale degli Infermi, U.O. Oncologia Medica

Rimini, Italy

Location

Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia

Roma, Italy

Location

Azienda Ospedaliera Universitaria Arcispedal, U.O. di Oncologia Clinica

Sant'Anna Di Ferrara, Italy

Location

Azienda Ospedaliera Di Busto Arsizio

Saronno, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, Italy

Location

Ospedale E. Morelli

Sondalo, Italy

Location

Azienda Sanitaria Locale 14

Verbania, Italy

Location

Ospedale S. Andrea

Vercelli, Italy

Location

Related Publications (3)

• Gridelli C, Ciardiello F, Gallo C, Feld R, Butts C, Gebbia V, Maione P, Morgillo F, Genestreti G, Favaretto A, Leighl N, Wierzbicki R, Cinieri S, Alam Y, Siena S, Tortora G, Felletti R, Riccardi F, Mancuso G, Rossi A, Cantile F, Tsao MS, Saieg M, da Cunha Santos G, Piccirillo MC, Di Maio M, Morabito A, Perrone F. First-line erlotinib followed by second-line cisplatin-gemcitabine chemotherapy in advanced non-small-cell lung cancer: the TORCH randomized trial. J Clin Oncol. 2012 Aug 20;30(24):3002-11. doi: 10.1200/JCO.2011.41.2056. Epub 2012 Jul 9.

  PMID: 22778317 RESULT

• Di Maio M, Leighl NB, Gallo C, Feld R, Ciardiello F, Butts C, Maione P, Gebbia V, Morgillo F, Wierzbicki R, Favaretto A, Alam Y, Cinieri S, Siena S, Bianco R, Riccardi F, Spatafora M, Ravaioli A, Felletti R, Fregoni V, Genestreti G, Rossi A, Mancuso G, Fasano M, Morabito A, Tsao MS, Signoriello S, Perrone F, Gridelli C. Quality of life analysis of TORCH, a randomized trial testing first-line erlotinib followed by second-line cisplatin/gemcitabine chemotherapy in advanced non-small-cell lung cancer. J Thorac Oncol. 2012 Dec;7(12):1830-1844. doi: 10.1097/JTO.0b013e318275b327.

  PMID: 23154555 RESULT

• Di Maio M, Gallo C, Leighl NB, Piccirillo MC, Daniele G, Nuzzo F, Gridelli C, Gebbia V, Ciardiello F, De Placido S, Ceribelli A, Favaretto AG, de Matteis A, Feld R, Butts C, Bryce J, Signoriello S, Morabito A, Rocco G, Perrone F. Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials. J Clin Oncol. 2015 Mar 10;33(8):910-5. doi: 10.1200/JCO.2014.57.9334. Epub 2015 Jan 26.

  PMID: 25624439 DERIVED

MeSH Terms

Interventions

Erlotinib Hydrochloride; Cisplatin; Gemcitabine

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Cesare Gridelli, M.D.

  S.G. Moscati Hospital, Avellino, Italy

  PRINCIPAL INVESTIGATOR

• Charles Butts, M.D.

  University of Alberta, Cross Cancer Institute, Edmonton, Alberta, Canada

  PRINCIPAL INVESTIGATOR

• Fortunato Ciardiello, M.D., Ph.D.

  Second University of Naples, Italy; Chair Medical Oncology

  PRINCIPAL INVESTIGATOR

• Ronald Feld, M.D.

  Princess Margaret Hospital, Divison of Medical Oncology, Toronto, Ontario, Canada

  PRINCIPAL INVESTIGATOR

• Ciro Gallo, M.D., Ph.D.

  Second University of Naples, Italy; Chair Medical Statistics

  PRINCIPAL INVESTIGATOR

• Francesco Perrone, M.D., Ph.D.

  National Cancer Institute, Naples, Italy; Director Clinical Trials Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2006
• First Posted: July 6, 2006
• Study Start: December 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

CA (15); IT (58)