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