Status:
COMPLETED
TORCH: A Study of Tarceva or Chemotherapy for the Treatment of Advanced Non Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute, Naples
Collaborating Sponsors:
San Giuseppe Moscati Hospital
Princess Margaret Hospital, Canada
Conditions:
Advanced Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 tre...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
760 Patients enrolled
Trial Details
Trial ID
NCT00349219
Start Date
December 1 2006
End Date
June 1 2012
Last Update
January 15 2016
Active Locations (73)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada
2
University of Alberta Cross Cancer Institute
Edmonton, Alberta, Canada
3
BC Cancer Agency Vancouver Island
Victoria, British Columbia, Canada
4
Cancer Care Mannitoba
Winnipeg, Manitoba, Canada