TORCH: A Study of Tarceva or Chemotherapy for the Treatment of Advanced Non Small Cell Lung Cancer
- Conditions
- Advanced Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00349219
- Lead Sponsor
- National Cancer Institute, Naples
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 760
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 gemcitabine erlotinib followed at progression by gemcitabine and cisplatin 1 erlotinib erlotinib followed at progression by gemcitabine and cisplatin 1 cisplatin erlotinib followed at progression by gemcitabine and cisplatin 2 cisplatin cisplatin and gemcitabine chemotherapy for 6 cycles, followed at progression by erlotinib 2 gemcitabine cisplatin and gemcitabine chemotherapy for 6 cycles, followed at progression by erlotinib 2 erlotinib cisplatin and gemcitabine chemotherapy for 6 cycles, followed at progression by erlotinib
- Primary Outcome Measures
Name Time Method overall survival one year progression free rate of first-line treatment with erlotinib after 9 weeks of treatment
- Secondary Outcome Measures
Name Time Method 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 response rate at 9 and 18 weeks from treatment initiation
Trial Locations
- Locations (73)
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Ospedale S. Vincenzo di Taormina
🇮🇹Taormina, ME, Italy
Ospedale Cardinal Massaia
🇮🇹Asti, Italy
C.R.O. Istituto Nazionale Tumori
🇮🇹Aviano, Italy
McGill University Cancer Centre
🇨🇦Montreal, Canada
Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Azienda Sanitaria S. Giuseppe Moscati
🇮🇹Monteforte Irpino, AV, Italy
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Istituto Regina Elena, Divisione di Oncologia Medica
🇮🇹Roma, Italy
Azienda Ospedaliera Morgagni Pierantoni
🇮🇹Forli', Italy
Istituto Oncologico Veneto
🇮🇹Padova, Italy
Ospedale S. Andrea
🇮🇹Vercelli, Italy
Hôpital Régional de Sudbury Regional Hospital
🇨🇦Sudbury, Ontario, Canada
ASL Viterbo Ospedale
🇮🇹Belcolle, (vt), Italy
Ospedale S. Martino
🇮🇹Genova, Italy
Ospedale Villa Scassi
🇮🇹Genova, Italy
Ospedale S. Maria Goretti
🇮🇹Latina, Italy
Policlinico Universitario P. Giaccone
🇮🇹Palermo, PA, Italy
Ospedale di Gaeta
🇮🇹Gaeta, LT, Italy
Ospedale di Prato
🇮🇹Prato, PO, Italy
Ospedale San Lazzaro
🇮🇹Alba, Italy
Ospedale Civile di Faenza, Divisione di Oncologia Medica
🇮🇹Faenza, RA, Italy
A.O. Ospedale Mater Domini, Oncoematologia Università Magna Grecia
🇮🇹Catanzaro, Italy
Ospedale Umberto I, U.O. di Oncologia Medica
🇮🇹Frosinone, Italy
A.O. Vito Fazzi
🇮🇹Lecce, Italy
Ospedale Mariano Santo, U.O. di Oncologia Medica
🇮🇹Cosenza, Italy
Azienda Ospedaliera Careggi
🇮🇹Firenze, Italy
Ospedale C. Poma
🇮🇹Mantova, Italy
Humanitas Centro Catanese di Oncologia
🇮🇹Catania, CT, Italy
Ospedale S. Corce
🇮🇹Fano, Italy
Divisione di Oncologia Medica, U.S.L.L. 13
🇮🇹Noale, Italy
Policlinico Universitario G. Martino
🇮🇹Messina, Italy
Casa di Cura IGEA
🇮🇹Milano, Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
🇮🇹Napoli, Italy
Ospedale Civile Umbero I
🇮🇹Nocera Inferiore, Italy
Niguarda Ca' Granda
🇮🇹Milano, Italy
Ospedale L. Sacco, GISCAD Oncologia, Polo Universitario
🇮🇹Milano, Italy
Buon Consiglio Fatebenefratelli
🇮🇹Napoli, Italy
Ospedale Cardarelli
🇮🇹Napoli, Italy
Second University of Naples
🇮🇹Napoli, Italy
Università Federico II, Cattedra di Oncologia Medica
🇮🇹Napoli, Italy
Ospedale Civile di Nola, Reparto di Oncologia
🇮🇹Nola, Italy
Ospedale Guglielmo da Saliceto
🇮🇹Piacenza, Italy
Azienda Ospedaliera Universitaria Arcispedal, U.O. di Oncologia Clinica
🇮🇹Sant'Anna di Ferrara, Italy
Azienda Sanitaria Locale 14
🇮🇹Verbania, Italy
Azienda Ospedaliera S. Carol
🇮🇹Potenza, Italy
Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
🇮🇹Roma, Italy
Ospedale degli Infermi, U.O. Oncologia Medica
🇮🇹Rimini, Italy
Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Italy
Ospedale E. Morelli
🇮🇹Sondalo, Italy
Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
BC Cancer Agency Vancouver Island
🇨🇦Victoria, British Columbia, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
University of Alberta Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Cancer Care Mannitoba
🇨🇦Winnipeg, Manitoba, Canada
QE II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Durham Regional Cancer Centre
🇨🇦Oshawa, Ontario, Canada
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
🇮🇹Bari, BA, Italy
Università di Chieti, Cattedra di Oncologia Medica
🇮🇹Chieti, CH, Italy
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
🇮🇹Palermo, PA, Italy
Ospedale S. Luca
🇮🇹Vallo della Lucania, SA, Italy
Azienda Ospedaliera G. Rummo, Unità Operativa di Oncologia Medica
🇮🇹Benevento, Italy
Azienda Ospedaliera V. Cervello
🇮🇹Palermo, PA, Italy
Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia
🇮🇹Pordenone, PN, Italy
Ospedale Senatore Antonio Perrino
🇮🇹Brindisi, Italy
Ospedale A. Cardarelli, divisione Medicina Interna
🇮🇹Campobasso, Italy
Ospedale Ramazzini, Day Hospital Oncologico
🇮🇹Carpi, Italy
Ospedale S. Salvatore
🇮🇹Pesaro, Italy
Fondazione Salvatore Maugeri
🇮🇹Pavia, Italy
Azienda Ospedaliera Di Busto Arsizio
🇮🇹Saronno, Italy