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

Information source: National Cancer Institute, Naples
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Advanced Non-Small Cell Lung Cancer

Intervention: erlotinib (Drug); cisplatin (Drug); gemcitabine (Drug); cisplatin (Drug); gemcitabine (Drug); erlotinib (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Cancer Institute, Naples

Official(s) and/or principal investigator(s):
Cesare Gridelli, M.D., Principal Investigator, Affiliation: S.G. Moscati Hospital, Avellino, Italy
Charles Butts, M.D., Principal Investigator, Affiliation: University of Alberta, Cross Cancer Institute, Edmonton, Alberta, Canada
Fortunato Ciardiello, M.D., Ph.D., Principal Investigator, Affiliation: Second University of Naples, Italy; Chair Medical Oncology
Ronald Feld, M.D., Principal Investigator, Affiliation: Princess Margaret Hospital, Divison of Medical Oncology, Toronto, Ontario, Canada
Ciro Gallo, M.D., Ph.D., Principal Investigator, Affiliation: Second University of Naples, Italy; Chair Medical Statistics
Francesco Perrone, M.D., Ph.D., Principal Investigator, Affiliation: National Cancer Institute, Naples, Italy; Director Clinical Trials Unit

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).

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

overall survival

progression free rate of first-line treatment with erlotinib

Secondary outcome:

toxicity

progression-free survival

quality of life during the first-line therapy

prognostic biologic indicators

resource utilization

response rate

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

McGill University Cancer Centre, Montreal, Canada

Ospedale San Lazzaro, Alba, Italy

Ospedale Cardinal Massaia, Asti, Italy

C.R.O. Istituto Nazionale Tumori, Aviano, Italy

Azienda Ospedaliera G. Rummo, Unità Operativa di Oncologia Medica, Benevento, Italy

Ospedale Senatore Antonio Perrino, Brindisi, Italy

Ospedale A. Cardarelli, divisione Medicina Interna, Campobasso, Italy

Ospedale Ramazzini, Day Hospital Oncologico, Carpi, Italy

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

Ospedale Mariano Santo, U.O. di Oncologia Medica, Cosenza, Italy

Ospedale S. Corce, Fano, Italy

Azienda Ospedaliera Careggi, Firenze, Italy

Azienda Ospedaliera Morgagni Pierantoni, Forli', Italy

Ospedale Umberto I, U.O. di Oncologia Medica, Frosinone, Italy

Ospedale S. Martino, Genova, Italy

Ospedale Villa Scassi, Genova, Italy

Ospedale S. Maria Goretti, Latina, Italy

A.O. Vito Fazzi, Lecce, Italy

Ospedale C. Poma, Mantova, Italy

Policlinico Universitario G. Martino, Messina, Italy

Casa di Cura IGEA, Milano, Italy

Niguarda Ca' Granda, Milano, Italy

Ospedale L. Sacco, GISCAD Oncologia, Polo Universitario, Milano, Italy

Buon Consiglio Fatebenefratelli, Napoli, Italy

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B, Napoli, Italy

Ospedale Cardarelli, Napoli, Italy

Second University of Naples, Napoli, Italy

Università Federico II, Cattedra di Oncologia Medica, Napoli, Italy

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

Ospedale Civile Umbero I, Nocera Inferiore, Italy

Ospedale Civile di Nola, Reparto di Oncologia, Nola, Italy

Istituto Oncologico Veneto, Padova, Italy

Fondazione Salvatore Maugeri, Pavia, Italy

Ospedale S. Salvatore, Pesaro, Italy

Ospedale Guglielmo da Saliceto, Piacenza, Italy

Azienda Ospedaliera S. Carol, Potenza, Italy

Ospedale degli Infermi, U.O. Oncologia Medica, Rimini, Italy

Istituto Regina Elena, Divisione di Oncologia Medica, Roma 00144, Italy

Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia, Roma, Italy

Azienda Ospedaliera Universitaria Arcispedal, U.O. di Oncologia Clinica, Sant'Anna di Ferrara, Italy

Azienda Ospedaliera Di Busto Arsizio, Saronno, Italy

Azienda Ospedaliera Universitaria Senese, Siena, Italy

Ospedale E. Morelli, Sondalo, Italy

Azienda Sanitaria Locale 14, Verbania, Italy

Ospedale S. Andrea, Vercelli, Italy

ASL Viterbo Ospedale, Belcolle, (vt), Italy

Azienda Sanitaria S. Giuseppe Moscati, Monteforte Irpino, AV, Italy

Tom Baker Cancer Centre, Calgary, Alberta, Canada

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

Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale, Bari, BA 70126, Italy

BC Cancer Agency Vancouver Island, Victoria, British Columbia, Canada

Università di Chieti, Cattedra di Oncologia Medica, Chieti, CH, Italy

Humanitas Centro Catanese di Oncologia, Catania, CT, Italy

Ospedale di Gaeta, Gaeta, LT 04024, Italy

Ospedale S. Vincenzo di Taormina, Taormina, ME, Italy

Cancer Care Mannitoba, Winnipeg, Manitoba, Canada

QE II Health Sciences Centre, Halifax, Nova Scotia, Canada

Juravinski Cancer Centre, Hamilton, Ontario, Canada

Kingston Regional Cancer Centre, Kingston, Ontario, Canada

Credit Valley Hospital, Mississauga, Ontario, Canada

Durham Regional Cancer Centre, Oshawa, Ontario, Canada

Hôpital Régional de Sudbury Regional Hospital, Sudbury, Ontario, Canada

Mount Sinai Hospital, Toronto, Ontario, Canada

Princess Margaret Hospital, Toronto, Ontario, Canada

Windsor Regional Cancer Centre, Windsor, Ontario, Canada

Azienda Ospedaliera V. Cervello, Palermo, PA, Italy

Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico, Palermo, PA 90146, Italy

Policlinico Universitario P. Giaccone, Palermo, PA 90100, Italy

Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia, Pordenone, PN 33170, Italy

Ospedale di Prato, Prato, PO 59100, Italy

Ospedale Civile di Faenza, Divisione di Oncologia Medica, Faenza, RA 48018, Italy

Ospedale S. Luca, Vallo della Lucania, SA, Italy

Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada

Additional Information

Related publications:

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.

Starting date: December 2006
Last updated: July 12, 2012

Page last updated: August 23, 2015

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