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

NCT00816868 | Completed Phase 2 DMC

• 1 other identifier: C-TONG 0807
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

stage IIIB/IV adenocarcinoma non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• objective response rate (CR + PR)

  2 year

• duration of response

  2 years

Study Arms (1)

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

Interventions

erlotinib in combination with capecitabine DRUG

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.

Also known as: Tavceva, Xeloda

non-small cell lung cancer (NSCLC)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center of Sun Yat-Sen University (CCSU)

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• Zhao HY, Chen GY, Huang Y, Li XL, Feng JF, Shi MQ, Cheng Y, Ma LX, Zhang YP, Gu CP, Song XQ, Zhou D, Zhang L. Erlotinib plus capecitabine as first-line treatment for older Chinese patients with advanced adenocarcinoma of the lung (C-TONG0807): an open-label, single arm, multicenter phase II study. Medicine (Baltimore). 2015 Jan;94(2):e249. doi: 10.1097/MD.0000000000000249.

  PMID: 25590835 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Capecitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Li Zhang, MD

  Cancer Center of Sun Yat-Sen University (CCSU)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 2, 2009
• First Posted: January 5, 2009
• Study Start: January 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 1, 2012

Record last verified: 2012-02

Locations

CN (1)