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A Study of TX Regimen as First-Line Treatment in Elderly Patients With Stage IIIB/IV Adenocarcinoma Non-Small Cell Lung Cancer (NCSLC)
This study is currently recruiting participants.
Verified by Sun Yat-sen University, May 2009
First Received: January 2, 2009   Last Updated: May 22, 2009   History of Changes
Sponsored by: Sun Yat-sen University
Information provided by: Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00816868
  Purpose

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) [13], the investigators previously conducted a phase II study of erlotinib in combination with capecitabine against NSCLC.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: erlotinib in combination with capecitabine
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Non-progression rate (CR + PR + SD) at week 12 and 18 [ Time Frame: Dec 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • objective response rate (CR + PR) duration of response TTP PFS Overall survival Safety QoL [ Time Frame: Dec 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
non-small cell lung cancer (NSCLC): Experimental
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 othersystemic 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816868

Contacts
Contact: Li Zhang, MD 86-20-87343458 zhangli6@mail.sysu.edu.cn

Locations
China, Guangdong
Cancer Center of Sun Yat-Sen University (CCSU) Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Li Zhang, MD         zhangli6@mail.sysu.edu.cn    
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Chair: Li Zhang, MD Cancer Center of Sun Yat-Sen University (CCSU)
  More Information

No publications provided

Responsible Party: Cancer Center of Sun Yat-sen University ( Cancer Center of Sun Yat-sen University )
Study ID Numbers: C-TONG 0807
Study First Received: January 2, 2009
Last Updated: May 22, 2009
ClinicalTrials.gov Identifier: NCT00816868     History of Changes
Health Authority: China: State Food and Drug Administration

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

Study placed in the following topic categories:
Thoracic Neoplasms
Erlotinib
Antimetabolites
Capecitabine
Protein Kinase Inhibitors
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

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

ClinicalTrials.gov processed this record on September 02, 2009