Overview

Individualized Therapy Based of Tumoral mRNA Levels of ERCC1, RRM1 and BRCA1 in Advanced Non-Small-Cell Lung Cancer

Status:
Terminated
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
Summary
This is a prospective pilot phase II trial, in patients with wet stage IIIb and IV NSCLC using chemotherapy regimens which will be defined according to the pharmacogenomic profile (tumoral expression of ERCC1, BRCA1 and RRM1) of the tumor cells.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hellenic Oncology Research Group
Collaborator:
University Hospital of Crete
Treatments:
Cisplatin
Docetaxel
Gemcitabine
Pemetrexed
Vinorelbine
Criteria
Inclusion Criteria:

- Patients with histologically proven Stage IV and Stage III (with malignant pleural or
pericardial effusion) squamous or adenocarcinoma carcinomas of the lung

- Adequate Formalin Fixed Paraffin Embedded tumor sample provided for molecular analysis

- No previous anticancer treatment for metastatic/advanced disease. Patients who
received prior adjuvant chemotherapy are eligible if they have remained free of
disease for at least 6 months after the completion of adjuvant therapy.

- Age above 18 years

- Performance status (ECOG) 0-2

- Life expectancy >= 3 months

- Effective contraception for both male and female subjects if the risk of conception
exists

- Adequate hematologic parameters (absolute neutrophil count >= 1.5x109/L and platelets
>= 100x109/L), creatinine (GFR>= 60ml/min) and total bilirubin < 1.5 times the upper
limit of normal; aspartate and alanine aminotransferase < 2,5 times the upper limit of
normal

- All patients will have to sign written informed consent in order to participate in the
study

Exclusion Criteria:

- Patients with non-squamous tumors who have no contradiction for administration of
bevacizumab

- Active infection or malnutrition (loss of more than 20% of the body weight)

- Known hypersensitivity reaction to any of the component of the treatment

- Concurrent or previous chronic systemic immune therapy

- Pregnancy (absence to be confirmed by ß-HCG test) or lactation period

- Known alcohol/drug abuse

- Legal incapacity or limited legal capacity

- Medical or psychological condition which in the opinion of the investigator would not
permit the subject to complete the study or sign meaningful informed consent

- A second primary tumor other than non-melanoma skin cancer or in situ cervical
carcinoma

- Previous radiotherapy to the target lesions. Patients treated with palliative
radiotherapy had to have measurable metastatic disease outside the irradiation fields

- Patients with severe cardiac dysfunction, unstable angina petrosis, or high risk of
uncontrolled arrhythmia