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

NCT ID: NCT01037998

Last Updated: 2009-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non-Small-Cell Lung Cancer

Keywords

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adenocarcinoma non-small-cell lung cancer gefitinib UFUR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Iressa 250 mg daily treatment plus UFUR twice daily treatment

Group Type ACTIVE_COMPARATOR

UFUR and Iressa

Intervention Type DRUG

Iressa 250 mg daily plus UFUR 1# bid

B

Gefitinib 250 mg daily treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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UFUR and Iressa

Iressa 250 mg daily plus UFUR 1# bid

Intervention Type DRUG

Other Intervention Names

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UFUR

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Chest Department

Principal Investigators

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Yuh-Min Chen, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Chest Department, Taipei VGH

Locations

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Taipei VGH

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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94-09-03

Identifier Type: -

Identifier Source: org_study_id