A Feasibility Study With Iressa in Resistant Cytokeratin-Positive Tumor Cells Circulating in the Blood of Women With Breast Cancer
NCT ID: NCT00428896
Last Updated: 2008-07-21
Study Results
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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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2005-04-30
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
ZD1839
ZD1839
ZD1839 will be given at the dose of 250mg/day for a minimum of 3 months
Interventions
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ZD1839
ZD1839 will be given at the dose of 250mg/day for a minimum of 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed breast cancer
* Metastatic breast cancer (stage IIIB and IV)
* Patients should have received at least one course of standard systemic chemotherapy for their metastatic disease. There should be at least one month between end of chemotherapy treatment and trial entry.
* ER+ve patients should have received adjuvant hormonal treatment
* Detection of CK-19 mRNA positive cells in the blood by real time PCR despite the previous administration of chemotherapy and if appropriate hormonal therapy
* Aged 18 years and over
* Paraffin-embedded tissue available for tumour histology (EGFR testing, ER, PgR, Her-2-neu testing)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
* Patients willing to undergo regular detection of circulating occult tumour cells in the blood by immunocytochemistry and/or RT-PCR
* Life expectancy of at least 12 weeks
Exclusion Criteria
* Known severe hypersensitivity to ZD1839 or any of the excipients of this product
* Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
* Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR)
* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
* Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 3 times the ULRR.
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
* Pregnancy or breast feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
* Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
* Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
18 Years
75 Years
FEMALE
No
Sponsors
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University Hospital of Crete
OTHER
Responsible Party
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University Hospital of Crete
Principal Investigators
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Vassilis Georgoulias, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Crete, Dep of Medical Oncology
Locations
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University Hospital of Crete
Heraklion, Crete, Greece
Countries
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References
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Kalykaki A, Agelaki S, Kallergi G, Xyrafas A, Mavroudis D, Georgoulias V. Elimination of EGFR-expressing circulating tumor cells in patients with metastatic breast cancer treated with gefitinib. Cancer Chemother Pharmacol. 2014 Apr;73(4):685-93. doi: 10.1007/s00280-014-2387-y. Epub 2014 Feb 4.
Other Identifiers
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MICRO
Identifier Type: -
Identifier Source: org_study_id