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Pazopanib Hydrochloride With or Without Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Squamous Non-Small Cell Lung Cancer Previously Treated With Bevacizumab

2014-07-23 21:09:29 | BioPortfolio

Summary

RATIONALE: Pazopanib hydrochloride and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects and how well giving pazopanib hydrochloride together with or without pemetrexed disodium works in treating patients with stage III or stage IV non-squamous non-small cell lung cancer previously treated with bevacizumab.

Description

OBJECTIVES:

Primary

- To estimate the disease-control rate (complete response [CR] + partial response [PR] + stable disease lasting ≥ 12 weeks as defined by RECIST criteria) of pazopanib hydrochloride with vs without pemetrexed disodium in patients with stage IIIB/IV non-squamous non-small cell lung cancer who progressed on first-line therapy containing bevacizumab as defined by RECIST criteria.

Secondary

- To estimate the combined response rate (CR + PR) in these patients according to RECIST criteria.

- To estimate the progression-free survival and overall survival of these patients.

- To evaluate the safety and tolerability of treatment using the NCI CTCAE version 4.0.

- To explore potential correlations between blood biomarkers and clinical benefit.

OUTLINE: This is a multicenter study. Patients who have been treated with prior pemetrexed disodium are assigned to group 1 and patients who have not been treated with pemetrexed disodium are assigned to group 2.

- Group 1 (pazopanib hydrochloride alone): Patients receive oral pazopanib hydrochloride on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

- Group 2 (pazopanib hydrochloride and pemetrexed disodium): Patients receive oral pazopanib hydrochloride on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for biomarker analysis.

After completion of study therapy, patients are followed up every 2 months for 2 years.

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

pazopanib hydrochloride, pemetrexed disodium

Status

Suspended

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:29-0400

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Medical and Biotech [MESH] Definitions

A quinazoline derivative and ANTINEOPLASTIC AGENT that functions as a PROTEIN KINASE INHIBITOR for EGFR associated tyrosine kinase. It is used in the treatment of NON-SMALL CELL LUNG CANCER.

Tumors or cancer of the LUNG.

A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Methadone is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

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.

Nuclear phosphoprotein encoded by the p53 gene (GENES, P53) whose normal function is to control CELL PROLIFERATION and APOPTOSIS. A mutant or absent p53 protein has been found in LEUKEMIA; OSTEOSARCOMA; LUNG CANCER; and COLORECTAL CANCER.

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