NCT01037998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

Enrollment Period

4.1 years

First QC Date

May 27, 2008

Last Update Submit

December 22, 2009

Conditions

Non-Small-Cell Lung Cancer

Keywords

adenocarcinomanon-small-cell lung cancergefitinibUFUR

Outcome Measures

Primary Outcomes (1)

  • To assess and compared the 6-month survival rate of these two arms of treatment.

    6 months

Secondary Outcomes (1)

  • To assess and compared the progression-free survival, overall survival, the response rate, and the toxicity profiles of these two arms of treatment.

    6 months

Study Arms (2)

A

ACTIVE COMPARATOR

Iressa 250 mg daily treatment plus UFUR twice daily treatment

Drug: UFUR and Iressa

B

NO INTERVENTION

Gefitinib 250 mg daily treatment

Interventions

UFUR and IressaDRUG

Iressa 250 mg daily plus UFUR 1# bid

Also known as: UFUR
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei VGH

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungAdenocarcinoma

Interventions

TegafurGefitinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

FluorouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Yuh-Min Chen, MD, PhD.

    Chest Department, Taipei VGH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 27, 2008

First Posted

December 23, 2009

Study Start

November 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 23, 2009

Record last verified: 2009-12

Locations

TW(1)