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

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.
ClinicalTrials.gov Identifier: NCT01037998
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : December 23, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Drug: UFUR and Iressa Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Adding UFUR to Non-small-cell Lung Cancer Patients Treated With Iressa
Study Start Date : November 2005
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. To assess and compared the 6-month survival rate of these two arms of treatment. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

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

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