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

NCT00428896 | Completed Phase 2

• 1 other identifier: MICRO
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Breast cancer; iressa circulating tumor cells

Outcome Measures

Primary Outcomes (1)

• Efficacy of ZD1839 by quantitative analysis of CK-19 mRNA CTCs

  Detection of CK-19 mRNA CTCs during and after the completion of ZD1839 treatment

Secondary Outcomes (3)

• To assess duration of response by means of CK-19 mRNA detection

  6 months

• To assess Progression Free Survival by means of CK-19 mRNA detection

  1 year

• To assess the safety of ZD1839 administration in this patient population

  Toxicity assessment every month

Study Arms (1)

1

EXPERIMENTAL

ZD1839

Drug: ZD1839

Interventions

ZD1839 DRUG

ZD1839 will be given at the dose of 250mg/day for a minimum of 3 months

Also known as: Iressa

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Crete: lead

Study Sites (1)

University Hospital of Crete

Heraklion, Crete, 71110, Greece

Location

Related Publications (1)

• 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.

  PMID: 24493157 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Vassilis Georgoulias, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 30, 2007
• Study Start: April 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: July 21, 2008

Record last verified: 2008-07

Locations

GR (1)