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
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: ZD1839
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University Hospital of Crete:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: April 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ZD1839
Drug: ZD1839
ZD1839 will be given at the dose of 250mg/day for a minimum of 3 months
Other Name: Iressa

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428896

Locations
Greece
University Hospital of Crete
Heraklion, Crete, Greece, 71110
Sponsors and Collaborators
University Hospital of Crete
Investigators
Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete, Dep of Medical Oncology
  More Information

No publications provided by University Hospital of Crete

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: V.Georgoulias, University Hospital of Crete
ClinicalTrials.gov Identifier: NCT00428896     History of Changes
Other Study ID Numbers: MICRO
Study First Received: January 29, 2007
Last Updated: July 18, 2008
Health Authority: Greece: National Organization of Medicines

Keywords provided by University Hospital of Crete:
Breast cancer
iressa circulating tumor cells

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014