Tarceva Italian Lung Optimization tRial - NCT00637910-Roma - 0036 (Clinical Trial 209597)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy209597.aspx
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Roma |
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Country:
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Italy |
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| Conditions: |
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Non Small Cell Lung Cancer (NSCLC) |
| Purpose: |
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The aim of this study is to assess whether clinical and biological features are able to
predict efficacy of Tyrosine kinase inhibitors.
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| Study summary: |
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Erlotinib is registered in all patients affected with NSCLC in second and subsequent lines
with a small benefit. Recent evidence suggest that it should be possible to select patients
according with clinical and biological features. However, most of these proofs are drawn
from case series or post hoc analyses and not from properly planned randomized clinical
trials rendering their interpretation controversial. EGFR mutations, EGFR copy number and
EGFR expression should positive select responders, while K-ras mutations should predict a
negative outcome.
Moreover, recent studies showed that similar information might be drawn also on blood
samples.
While it is possible to assume that in patients with EGFR mutations erlotinib improves
Overall Survival (OS) and gives prolonged and high responses, the role of erlotinib in
patients without EGFR mutations is controversial.
On this assumption, the predictive value of K-ras mutations, EGFR protein expression and
EGFR gene copy number in determining the effect of erlotinib as compared with chemotherapy
will be assessed in patients without EGFR mutations.
Aim of the study is to assess whether it is possible to optimize second-line treatment in
NSCLC using biological and clinical markers. |
| Criteria: |
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Inclusion Criteria:
- Age 18 years or older
- Histological or cytological confirmation of NSCLC (may be from initial diagnosis of
NSCLC or subsequent biopsy). Only patients with available tissue samples may be
included in the study
- Absence of EGFR mutations of exons 19 or 21 (randomization)
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or
radiotherapy
- One prior platinum-based at adequate doses and taxane free regimen
- Measurable (uni-dimensional) disease by RECIST in a lesion not previously irradiated
or non-measurable disease
- ECOG-PS 0-2
- ANC greater than 1.5 x 109/L and platelets greater than 100 x 109/L
- Bilirubin level either normal or <1.5xULN
- AST (SGOT) and ALT (SGPT) <2.5xULN (≤5 x ULN if liver metastases are present)
- Serum creatinine <1.5xULN
- Effective contraception for both, male and female pts, if the risk of conception
exists
- Recovery from all acute toxicities of prior therapies
- Provision of written informed consent to the analysis of biological markers
(registration)
- Provision of written informed consent to enter the randomized part of the study
(randomization)
Exclusion Criteria:
- Prior therapy with an experimental agent whose primary mechanism of action is
inhibition of EGFR or its associated tyrosine kinase
- Prior chemotherapy with taxanes
- Newly diagnosed CNS metastases that have not yet been treated with surgery and/or
radiation. Pts with previously diagnosed and treated CNS metastases or spinal cord
compression may be considered if they have evidence of clinically SD (no steroid
therapy or steroid dose being tapered) for at least 28 daysLess than 14 days since
completion of prior radiotherapy or persistence of any radiotherapy related toxicity
- Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion
of the investigator, makes it inappropriate for the patient to be enrolled in the
study Known severe hypersensitivity to erlotinib or any of the excipients of this
product
- Known hypersensitivity to docetaxel, polysorbate 80 or other drugs formulated with
polysorbate 80, or any of the excipients of docetaxel
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with
the exception of basal cell carcinoma or cervical cancer in situ
- Unable to swallow tablets
- Any evidence of clinically active interstitial lung disease (patients with chronic,
stable, radiographic changes who are asymptomatic or patients with uncomplicated
progressive lymphangitic carcinomatosis need not be excluded)
- As judged by the investigator, any evidence of severe or uncontrolled systemic
disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal
disease)
- As judged by the investigator, any inflammatory changes of the surface of the eye
- Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the patient to participate in the study |
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| Study is available at: |
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Madonna della Fiducia Hospital
Roma
Italy
Primary Contact:
Sergio Del Bianco, MD
Email: sergio.delbianco@fiducia.it
Phone: +39 0678462786
Secondary Contact:
Marina C Garassino, MD
Email: marina.garassino@fbf.milano.it
Phone: +39 0263632223 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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