A Phase II Study of TX Regimen as First-line Treatment for Asian Elderly Patients With Advanced Adenocarcinoma of Lung
This study has been completed.
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
First received: January 2, 2009
Last updated: February 28, 2012
Last verified: February 2012
Because of the effect in the treatment of NSCLC, the capecitabine and erlotinib may compose to a new regimen for NSCLC. Based on the preclinical observation and the confirmed clinical synergistic anti-tumor activity of combined capecitabine and erlotinib in gemzar refractory advanced pancreatic cancer (APC), the investigators previously conducted a phase II study of erlotinib in combination with capecitabine against NSCLC.
Non-small Cell Lung Cancer
Drug: erlotinib in combination with capecitabine
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Study of Erlotinib in Combination With Capecitabine as First-line Treatment in Elderly Patients With Stage IIIB/IV Adenocarcinoma Non-small Cell Lung Cancer (NSCLC)
Primary Outcome Measures:
Secondary Outcome Measures:
- objective response rate (CR + PR) [ Time Frame: 2 year ] [ Designated as safety issue: No ]
- duration of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2010 (Final data collection date for primary outcome measure)
Experimental: non-small cell lung cancer (NSCLC)
erlotinib in combination with capecitabine as first-line treatment in elderly patients with stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC)
Drug: erlotinib in combination with capecitabine
Erlotinib 150 mg Q.D. orally for 21 days plus Capecitabine 1000 mg/m2 twice daily for 2 weeks followed by 1 week break every 21 days Until PD, unacceptable toxicity or death.
|Ages Eligible for Study:
||65 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histological or cytological documented stage IIIB (not amenable for radical /loco-regional therapy) or stage IV (metastatic) adenocarcinoma of lung. Sputum cytology alone is excluded.
- Measurable disease, according to the Response Evaluation Criteria in Solid Tumours (RECIST), the presence of at least one unidimensionally measurable lesion with longest diameter ≥ 20 mm by conventional techniques OR 10 mm by spiral CT scan.
- Age ≥ 65.
- Life expectancy of at least 3 months.
- Never previously treated with radiotherapy, chemotherapy or surgery for malignant disease.
- Neutrophil count ≥ 1.5 × 109/L or platelets ≥ 75× 109/L or hemoglobin ≥ 10g/dL
- Adequate hepatic function including prothrombin time ≥70%of the reference, AST/ALT ≤2.5×institutional upper limit of normal (ULN) or ≤5×ULN if liver metastases, alkaline phosphatase ≤5×ULN (or ≤20×ULN if liver metastases),total bilirubin ≤1.5×ULN
- Male or female. Age ≥ 18 years.
- Written (signed) informed consent.
- Able to comply with study and follow-up procedures.
- Patients with prior surgery or thoracic radiotherapy.
- Patients with prior chemotherapy or other systemic anti-tumour therapy (e.g. monoclonal antibody therapy or EGFR-TKI) .
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active peptic ulcer disease.
- Any inflammatory changes of the surface of the eye.
- Any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication (Erlotinib,Capecitabine) or that might affect the interpretation of the results or render the subject at high risk from treatment complications.
- Pregnant or lactating women.
- Woman of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
- History of another malignancy within the last 5 years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
- Patient who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids are excluded.
- Patients who have brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation will be excluded; 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 be excluded.
- Hypersensitivity to Erlotinib or Capecitabine
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816868
|Cancer Center of Sun Yat-Sen University (CCSU)
|Guangzhou, Guangdong, China, 510000 |
Sun Yat-sen University
||Li Zhang, MD
||Cancer Center of Sun Yat-Sen University (CCSU)
No publications provided
||Li Zhang, Professor, Sun Yat-sen University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 2, 2009
||February 28, 2012
||China: Food and Drug Administration
Keywords provided by Sun Yat-sen University:
stage IIIB/IV adenocarcinoma non-small cell lung cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 15, 2014
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors