A Phase II Study of TX Regimen as First-line Treatment for Asian Elderly Patients With Advanced Adenocarcinoma of Lung

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00816868
Recruitment Status : Completed
First Posted : January 5, 2009
Last Update Posted : March 1, 2012
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: erlotinib in combination with capecitabine Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : January 2009
Primary Completion Date : May 2010
Study Completion Date : March 2011

Arm Intervention/treatment
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.
Other Names:
  • Tavceva
  • Xeloda

Primary Outcome Measures :
  1. Non-progression rate (CR + PR + SD) at week 12 and 18 [ Time Frame: 1 year ]
    the percentage of patients who got a complete response, partial response and stable disease at week 12 and at week 18

Secondary Outcome Measures :
  1. objective response rate (CR + PR) [ Time Frame: 2 year ]
  2. duration of response [ Time Frame: 2 years ]

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00816868

China, Guangdong
Cancer Center of Sun Yat-Sen University (CCSU)
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Sun Yat-sen University
Study Chair: Li Zhang, MD Cancer Center of Sun Yat-Sen University (CCSU)

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Li Zhang, Professor, Sun Yat-sen University Identifier: NCT00816868     History of Changes
Other Study ID Numbers: C-TONG 0807
First Posted: January 5, 2009    Key Record Dates
Last Update Posted: March 1, 2012
Last Verified: February 2012

Keywords provided by Li Zhang, Sun Yat-sen University:
stage IIIB/IV adenocarcinoma non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors