A Feasibility Study With Iressa in Resistant Cytokeratin-Positive Tumor Cells Circulating in the Blood of Women With Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
University Hospital of Crete
ClinicalTrials.gov Identifier:
NCT00428896
First received: January 29, 2007
Last updated: July 18, 2008
Last verified: July 2008

January 29, 2007
July 18, 2008
April 2005
March 2008   (final data collection date for primary outcome measure)
Efficacy of ZD1839 by quantitative analysis of CK-19 mRNA CTCs [ Time Frame: Detection of CK-19 mRNA CTCs during and after the completion of ZD1839 treatment ] [ Designated as safety issue: No ]
  • The efficacy of ZD1839 will be measured by quantitative analysis of circulating tumour
  • cells in the blood before, during and after the completion of ZD1839 treatment
  • using two different quantitative methodologies:
  • Immunocytochemical detection with an anti-pancytokeratin antibody (A45B3/3)
  • and positive cell enumeration using the Automated Cellular Imaging System
  • Real-time PCR for CK-19 mRNA using the LightCycler Instrument
Complete list of historical versions of study NCT00428896 on ClinicalTrials.gov Archive Site
  • To assess duration of response by means of CK-19 mRNA detection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess Progression Free Survival by means of CK-19 mRNA detection [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To assess the safety of ZD1839 administration in this patient population [ Time Frame: Toxicity assessment every month ] [ Designated as safety issue: Yes ]
  • To assess duration of response by means of CK-19 mRNA detection
  • To assess Progression Free Survival by means of CK-19 mRNA detection
  • To assess the safety of ZD1839 administration in this patient population
Not Provided
Not Provided
 
A Feasibility Study With Iressa in Resistant Cytokeratin-Positive Tumor Cells Circulating in the Blood of Women With Breast Cancer
A Pilot Feasibility Study to Evaluate the Efficacy of ZD1839 (IRESSA) in Eliminating Chemo- and Hormone- Resistant Cytokeratin-Positive Tumour Cells Circulating in the Blood of Women With Breast Cancer

Based on preclinical data, ZD1839 is considered a novel and promising therapeutic approach with potential application in the treatment of human breast cancer. Therefore it could be very important and clinically relevant to know if ZD1839 is capable of eliminating occult tumour cells circulating in the blood of breast cancer patients

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: ZD1839
ZD1839 will be given at the dose of 250mg/day for a minimum of 3 months
Other Name: Iressa
Experimental: 1
ZD1839
Intervention: Drug: ZD1839
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provision of written informed consent
  • 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:

  • Any concurrent systemic treatment for breast cancer (including chemotherapy, radiotherapy, hormonotherapy, monoclonal antibodies)
  • 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
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00428896
MICRO
Not Provided
V.Georgoulias, University Hospital of Crete
University Hospital of Crete
Not Provided
Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete, Dep of Medical Oncology
University Hospital of Crete
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP