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

January 14, 2016 updated by: National Cancer Institute, Naples

An International Randomized Phase III Study of First-line Erlotinib Followed by Second-line Cisplatin + Gemcitabine Versus First-line Cisplatin + Gemcitabine Followed by Second-line Erlotinib in Advanced Non Small Cell Lung Cancer

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).

Study Overview

Detailed Description

Chemotherapy for patients affected by advanced NSCLC has demonstrated only modest improvement in survival rates over best supportive care: the prognosis of patients remains poor and the side effects are considerable. Therefore, novel agents are urgently needed for this disease. One way to improve effectiveness of therapies is to use non-chemotherapeutic agents that act on biological targets and cause fewer systemic side effects. Erlotinib(Tarceva)is a biological therapy that in recent clinical trials has shown promise in first- and second-line treatment of advanced NSCLC.

In this trial, patients will be randomized to one of two treatment strategies:

- erlotinib taken by mouth daily; and, if disease progression occurs, to be followed by chemotherapy with cisplatin and gemcitabine at standard doses for 6 cycles

OR

- chemotherapy with cisplatin and gemcitabine given intravenously at standard doses for 6 cycles; and if disease progression occurs to be followed by erlotinib taken by mouth daily

The study is conducted with the partial support of Roche, S.p.A.

Study Type

Interventional

Enrollment (Actual)

760

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Montreal, Canada
        • McGill University Cancer Centre
    • Alberta
      • Calgary, Alberta, Canada
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada
        • University of Alberta Cross Cancer Institute
    • British Columbia
      • Victoria, British Columbia, Canada
        • BC Cancer Agency Vancouver Island
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Cancer Care Mannitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • QE II Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada
        • Juravinski Cancer Centre
      • Kingston, Ontario, Canada
        • Kingston Regional Cancer Centre
      • Mississauga, Ontario, Canada
        • Credit Valley Hospital
      • Oshawa, Ontario, Canada
        • Durham Regional Cancer Centre
      • Sudbury, Ontario, Canada
        • Hôpital Régional de Sudbury Regional Hospital
      • Toronto, Ontario, Canada
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada
        • Princess Margaret Hospital
      • Windsor, Ontario, Canada
        • Windsor Regional Cancer Centre
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Saskatoon Cancer Centre
      • Alba, Italy
        • Ospedale San Lazzaro
      • Asti, Italy
        • Ospedale Cardinal Massaia
      • Aviano, Italy
        • C.R.O. Istituto Nazionale Tumori
      • Benevento, Italy
        • Azienda Ospedaliera G. Rummo, Unità Operativa di Oncologia Medica
      • Brindisi, Italy
        • Ospedale Senatore Antonio Perrino
      • Campobasso, Italy
        • Ospedale A. Cardarelli, divisione Medicina Interna
      • Carpi, Italy
        • Ospedale Ramazzini, Day Hospital Oncologico
      • Catanzaro, Italy
        • A.O. Ospedale Mater Domini, Oncoematologia Università Magna Grecia
      • Cosenza, Italy
        • Ospedale Mariano Santo, U.O. di Oncologia Medica
      • Fano, Italy
        • Ospedale S. Corce
      • Firenze, Italy
        • Azienda Ospedaliera Careggi
      • Forli', Italy
        • Azienda Ospedaliera Morgagni Pierantoni
      • Frosinone, Italy
        • Ospedale Umberto I, U.O. di Oncologia Medica
      • Genova, Italy
        • Ospedale Villa Scassi
      • Genova, Italy
        • Ospedale S. Martino
      • Latina, Italy
        • Ospedale S. Maria Goretti
      • Lecce, Italy
        • A.O. Vito Fazzi
      • Mantova, Italy
        • Ospedale C. Poma
      • Messina, Italy
        • Policlinico Universitario G. Martino
      • Milano, Italy
        • Casa di Cura IGEA
      • Milano, Italy
        • Niguarda Ca' Granda
      • Milano, Italy
        • Ospedale L. Sacco, GISCAD Oncologia, Polo Universitario
      • Napoli, Italy
        • Second University of Naples
      • Napoli, Italy
        • Ospedale Cardarelli
      • Napoli, Italy
        • Università Federico II, Cattedra di Oncologia Medica
      • Napoli, Italy
        • Buon Consiglio Fatebenefratelli
      • Napoli, Italy
        • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
      • Noale, Italy
        • Divisione di Oncologia Medica, U.S.L.L. 13
      • Nocera Inferiore, Italy
        • Ospedale Civile Umbero I
      • Nola, Italy
        • Ospedale Civile di Nola, Reparto di Oncologia
      • Padova, Italy
        • Istituto Oncologico Veneto
      • Pavia, Italy
        • Fondazione Salvatore Maugeri
      • Pesaro, Italy
        • Ospedale S. Salvatore
      • Piacenza, Italy
        • Ospedale Guglielmo da Saliceto
      • Potenza, Italy
        • Azienda Ospedaliera S. Carol
      • Rimini, Italy
        • Ospedale degli Infermi, U.O. Oncologia Medica
      • Roma, Italy, 00144
        • Istituto Regina Elena, Divisione di Oncologia Medica
      • Roma, Italy
        • Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
      • Sant'Anna di Ferrara, Italy
        • Azienda Ospedaliera Universitaria Arcispedal, U.O. di Oncologia Clinica
      • Saronno, Italy
        • Azienda Ospedaliera Di Busto Arsizio
      • Siena, Italy
        • Azienda Ospedaliera Universitaria Senese
      • Sondalo, Italy
        • Ospedale E. Morelli
      • Verbania, Italy
        • Azienda Sanitaria Locale 14
      • Vercelli, Italy
        • Ospedale S. Andrea
    • (vt)
      • Belcolle, (vt), Italy
        • ASL Viterbo Ospedale
    • AV
      • Monteforte Irpino, AV, Italy
        • Azienda Sanitaria S. Giuseppe Moscati
    • BA
      • Bari, BA, Italy, 70126
        • Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
    • CH
      • Chieti, CH, Italy
        • Università di Chieti, Cattedra di Oncologia Medica
    • CT
      • Catania, CT, Italy
        • Humanitas Centro Catanese di Oncologia
    • LT
      • Gaeta, LT, Italy, 04024
        • Ospedale di Gaeta
    • ME
      • Taormina, ME, Italy
        • Ospedale S. Vincenzo di Taormina
    • PA
      • Palermo, PA, Italy, 90100
        • Policlinico Universitario P. Giaccone
      • Palermo, PA, Italy, 90146
        • Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
      • Palermo, PA, Italy
        • Azienda Ospedaliera V. Cervello
    • PN
      • Pordenone, PN, Italy, 33170
        • Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia
    • PO
      • Prato, PO, Italy, 59100
        • Ospedale di Prato
    • RA
      • Faenza, RA, Italy, 48018
        • Ospedale Civile di Faenza, Divisione di Oncologia Medica
    • SA
      • Vallo della Lucania, SA, Italy
        • Ospedale S. Luca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
erlotinib followed at progression by gemcitabine and cisplatin
erlotinib 150 mg taken orally daily until disease progression
Other Names:
  • Tarceva
cisplatin 80 mg/m2 IV day 1 every 3 weeks given in second-line therapy
gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks, given in second-line
cisplatin 80 mg/m2 IV day 1 every 3 weeks for 6 cycles
gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks for 6 cycles
erlotinib 150 mg orally taken daily as second line therapy (after disease progression on chemotherapy)
Other Names:
  • Tarceva
Active Comparator: 2
cisplatin and gemcitabine chemotherapy for 6 cycles, followed at progression by erlotinib
erlotinib 150 mg taken orally daily until disease progression
Other Names:
  • Tarceva
cisplatin 80 mg/m2 IV day 1 every 3 weeks given in second-line therapy
gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks, given in second-line
cisplatin 80 mg/m2 IV day 1 every 3 weeks for 6 cycles
gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks for 6 cycles
erlotinib 150 mg orally taken daily as second line therapy (after disease progression on chemotherapy)
Other Names:
  • Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: one year
one year
progression free rate of first-line treatment with erlotinib
Time Frame: after 9 weeks of treatment
after 9 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: one year
one year
toxicity
Time Frame: every 3 weeks during treatment, and every 3 months thereafter
every 3 weeks during treatment, and every 3 months thereafter
quality of life during the first-line therapy
Time Frame: every 3 weeks during first-line therapy
every 3 weeks during first-line therapy
prognostic biologic indicators
Time Frame: end of study
end of study
resource utilization
Time Frame: every 6 weeks during first-line therapy
every 6 weeks during first-line therapy
response rate
Time Frame: at 9 and 18 weeks from treatment initiation
at 9 and 18 weeks from treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ciro Gallo, M.D., Ph.D., Second University of Naples, Italy; Chair Medical Statistics
  • Principal Investigator: 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: Francesco Perrone, M.D., Ph.D., National Cancer Institute, Naples, Italy; Director Clinical Trials Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

July 4, 2006

First Submitted That Met QC Criteria

July 4, 2006

First Posted (Estimate)

July 6, 2006

Study Record Updates

Last Update Posted (Estimate)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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