Clinical trial NCT00428896: A Feasibility Study With Iressa in Resistant Cytokeratin-Positive Tumor Cells Circulating in the Blood of Women With Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast cancer
iressa circulating tumor cells
Lead sponsor: University Hospital of Crete
Sponsor class: OTHER
First posted: 2007-01-30
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Efficacy of ZD1839 by quantitative analysis of CK-19 mRNA CTCs
timeFrame: Detection of CK-19 mRNA CTCs during and after the completion of ZD1839 treatment
Secondary outcomes:
measure: To assess duration of response by means of CK-19 mRNA detection
timeFrame: 6 months
measure: To assess Progression Free Survival by means of CK-19 mRNA detection
timeFrame: 1 year
measure: To assess the safety of ZD1839 administration in this patient population
timeFrame: Toxicity assessment every month
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete
state: Crete
Study officials:
affiliation: University Hospital of Crete, Dep of Medical Oncology
name: Vassilis Georgoulias, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.