Non-small Cell Lung Cancer Clinical Trial
Official title:
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)
Verified date | February 2012 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | March 2011 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: 1. 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. 2. 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. 3. Age = 65. 4. Life expectancy of at least 3 months. 5. Never previously treated with radiotherapy, chemotherapy or surgery for malignant disease. 6. Neutrophil count = 1.5 × 109/L or platelets = 75× 109/L or hemoglobin = 10g/dL 7. 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 8. Male or female. Age = 18 years. 9. Written (signed) informed consent. 10. Able to comply with study and follow-up procedures. Exclusion Criteria: 1. Patients with prior surgery or thoracic radiotherapy. 2. Patients with prior chemotherapy or other systemic anti-tumour therapy (e.g. monoclonal antibody therapy or EGFR-TKI) . 3. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active peptic ulcer disease. 4. Any inflammatory changes of the surface of the eye. 5. 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. 6. Pregnant or lactating women. 7. 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. 8. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study. 9. 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). 10. History of another malignancy within the last 5 years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix. 11. Patient who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids are excluded. 12. 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. 13. Hypersensitivity to Erlotinib or Capecitabine |
Country | Name | City | State |
---|---|---|---|
China | Cancer Center of Sun Yat-Sen University (CCSU) | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Non-progression rate (CR + PR + SD) at week 12 and 18 | the percentage of patients who got a complete response, partial response and stable disease at week 12 and at week 18 | 1 year | |
Secondary | objective response rate (CR + PR) | 2 year | ||
Secondary | duration of response | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03087448 -
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
Recruiting |
NCT05042375 -
A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Terminated |
NCT05414123 -
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
|
||
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
Recruiting |
NCT05009836 -
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
|
Phase 3 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03219970 -
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
|
||
Recruiting |
NCT05949619 -
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04054531 -
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
|
Phase 2 | |
Withdrawn |
NCT03519958 -
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
|
||
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Terminated |
NCT02580708 -
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01871805 -
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1/Phase 2 | |
Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05919641 -
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
|
||
Completed |
NCT03656705 -
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
|
Phase 1 |