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Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib for Inoperable Stage III Non-Small Cell Lung Cancer

2014-08-27 03:40:53 | BioPortfolio

Summary

Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC.

Description

Outline: This is a multi-center study.

Chemotherapy/radiation therapy (2 cycles)

- Cisplatin 50 mg/m2 IV days 1 and 8 of 28 day cycle

- Etoposide 50 mg/m2 IV days 1-5 of 28 day cycle

- Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy) with the following:

Maintenance therapy of Sorafenib 400 mg PO BID of 28 day cycle, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 1 year.

Patients with progressive disease will discontinue treatment.

ECOG performance status 0 or 1

Hematopoietic:

- Absolute neutrophil count (ANC) ≥ 1500 mm3

- Platelet count ≥ 100,000 mm3

- Hemoglobin ≥ 9 g/dL

- PT or INR < 1.5 x ULN unless on anti-coagulant therapy

- PTT < 1.5 x ULN unless on anti-coagulant therapy

Hepatic:

- Bilirubin ≤ 1.5 x ULN

- ALT ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)

- AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)

Renal:

- Creatinine < 1.5 X upper limit of normal (ULN)

Cardiovascular:

- No significant history of cardiac disease: Congestive heart failure > class II NYHA.

- Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within 90 days prior to registration for initial therapy) or myocardial infarction within 6 months prior to registration for initial therapy.

Respiratory:

- FEV1 ≥ 1 liter by spirometry within 60 days prior to registration for initial therapy.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Non-Small Cell Lung Cancer

Intervention

Cisplatin, Etoposide, Radiotherapy, Sorafenib

Location

Medical & Surgical Specialists, LLC
Galesburg
Illinois
United States
61401

Status

Terminated

Source

Hoosier Oncology Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:40:53-0400

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Medical and Biotech [MESH] Definitions

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).

A semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.

A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.

An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.

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