UFUR (Tegafur/Uracil) Plus Iressa in Non-small-cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01037998
First received: May 27, 2008
Last updated: December 22, 2009
Last verified: December 2009
  Purpose

Iressa [epidermal growth factor tyrosine kinase inhibitor (EGFR-TKI)] has been reported to activity against Non-small-cell Lung Cancer (NSCLC) failed previous chemotherapy. UFUR was found to have anti-angiogenesis effect when long term treatment was given. Combination of EGFR-TKI and anti-angiogenesis agents is a novel treatment.


Condition Intervention Phase
Non-Small-Cell Lung Cancer
Drug: UFUR and Iressa
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Adding UFUR to Non-small-cell Lung Cancer Patients Treated With Iressa

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • To assess and compared the 6-month survival rate of these two arms of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess and compared the progression-free survival, overall survival, the response rate, and the toxicity profiles of these two arms of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 115
Study Start Date: November 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Iressa 250 mg daily treatment plus UFUR twice daily treatment
Drug: UFUR and Iressa
Iressa 250 mg daily plus UFUR 1# bid
Other Name: UFUR
No Intervention: B
Gefitinib 250 mg daily treatment

Detailed Description:

Iressa is a selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). It is an orally active agent for advanced non-small-cell lung cancer (NSCLC) in those who have failed a previous platinum-based regimen and taxane treatment. UFUR (Tegafur/Uracil) is effective agent against chemo-naïve NSCLC. It has anti-angiogenesis effect when used as long-term low dose treatment.

Present phase II randomized clinical trial is designed to answer whether or not adding an oral anti-angiogenesis agent (UFUR), that has low toxicity profiles when long term use, to EGFR-TKI (Iressa) could increase patients survival and response rate.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic or cytological diagnosis of NSCLC who failed previous platinum-based and taxanes chemotherapy.
  • No prior radiotherapy on measurable lesion(s).
  • Performance status of 0 to 3 on the Zubrod scale. (Reference 1)
  • Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical examination. Lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by CT scan, MRI, or chest x-ray.
  • Informed consent from patient.
  • Males or females 18 years of age or older.
  • If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device [IUD], birth control pills, or barrier device) during and for three months after trial.

Exclusion Criteria:

  • Active infection (at the discretion of the investigator).
  • Inadequate liver function (total bilirubin >1.5 times above normal range); alanine transaminase (ALT) and aspartate transaminase (AST) greater than 5 times normal.
  • Inadequate renal function (creatinine >2.0 mg/dL).
  • Breast feeding.
  • Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
  • Concomitant myelosuppressive radiotherapy, chemotherapy, hormonal therapy, or immunotherapy will not be allowed except as for palliative radiation to non-measurable lesion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037998

Locations
Taiwan
Taipei VGH
Taipei City, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Yuh-Min Chen, MD, PhD. Chest Department, Taipei VGH
  More Information

No publications provided

Responsible Party: Yuh-Min Chen, MD, PhD, Associate Professor, Chest Department
ClinicalTrials.gov Identifier: NCT01037998     History of Changes
Other Study ID Numbers: 94-09-03
Study First Received: May 27, 2008
Last Updated: December 22, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
adenocarcinoma
non-small-cell lung cancer
gefitinib
UFUR

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014