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Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer

2014-08-27 03:19:23 | BioPortfolio

Summary

Multi-center, open, randomized (parallel) and comparative phase III.

Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression.

Arm A: Bevacizumab + pemetrexed

Arm B: Bevacizumab + pemetrexed + carboplatin

Description

Primary:

- Proof of non-inferior efficacy of a monochemotherapy regimen of pemetrexed plus bevacizumab versus a combination chemotherapy regimen of pemetrexed-carboplatin plus bevacizumab in elderly patients(> 65 years) as first-line treatment of advanced metastatic or recurrent non-squamous NSCLC by progression free survival

Secondary:

- To assess the efficacy of bevacizumab as measured by overall response rate and overall survival.

- To assess the safety of bevacizumab in combination with pemetrexed and pemetrexed and carboplatin.

- To assess quality of life by EORTC questionnaire QLQ-C30 and its lung cancer module LC-13

- To assess activity of daily life (iADL) in relation to ECOG performance status prior to study treatment

- To assess patient`s outcome and treatment delivery in relation to the Charlson comorbidity score and the Simplified Comorbidity Score

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Non-squamous Non-small Cell Lung Cancer

Intervention

Bevacizumab + Pemetrexed, Bevacizumab + Pemetrexed + Carboplatin

Location

Krankenhaus Martha-Maria Halle-Doelau
Halle
Germany
06120

Status

Recruiting

Source

Martha-Maria Krankenhaus Halle-Dölau gGmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:23-0400

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Medical and Biotech [MESH] Definitions

A guanine-derived ANTINEOPLASTIC AGENT that functions as a NUCLEIC ACID SYNTHESIS INHIBITOR through its binding to, and inhibition of, THYMIDYLATE SYNTHASE.

An anti-VEGF recombinant monoclonal antibody consisting of humanized murine antibody. It inhibits VEGF receptors and prevents the proliferation of blood vessels.

Neoplasms composed of squamous cells of the epithelium. The concept does not refer to neoplasms located in tissue composed of squamous elements.

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.

Morphological abnormalities of the cervical EPITHELIUM, usually revealed in PAP SMEAR, which do not meet the criteria for squamous CERVICAL INTRAEPITHELIAL NEOPLASIA or SQUAMOUS CELL CARCINOMAS of the CERVIX . It may be a sign of infection with certain types of human papillomavirus (HPV).or sign of a benign (not cancer) growth, such as a cyst or polyp or, in menopausal women, of low hormone levels. More testing, such as HPV test, may be needed.

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