Advertisement

Topics

Carboplatin, Ixabepilone, and Cetuximab in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Untreated With Chemotherapy

2014-08-27 03:18:34 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with monoclonal antibodies may be a better way to block cancer growth.

PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin and ixabepilone together with cetuximab works in treating patients with stage III or stage IV non-small cell lung cancer previously untreated with chemotherapy.

Description

OBJECTIVES:

Primary

- To estimate the disease-control rate in patients with advanced chemotherapy-naive non-small cell lung cancer after 2 courses of carboplatin, ixabepilone, and cetuximab.

Secondary

- To estimate the progression-free survival of patients treated with this regimen.

- To estimate the overall survival of patients treated with this regimen.

- To estimate the toxicity of this regimen in these patients.

- To determine the potential predictive marker of efficacy of ixabepilone and cetuximab. (exploratory)

- To investigate the prevalence of cetuximab IgE antibody, and the rate of cetuximab hypersensitivity reactions in patients without evidence of cetuximab IgE antibodies.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 30 minutes and ixabepilone IV over 3 hours on day 1 and cetuximab IV over 1-2 hours on days 1, 8 and 15. Treatment repeats every 21 days for up to 2-4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.

Tumor tissue and blood samples are collected for further analysis.

After completion of study therapy, patients are followed periodically.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

cetuximab, carboplatin, ixabepilone, laboratory biomarker analysis

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:34-0400

Clinical Trials [6210 Associated Clinical Trials listed on BioPortfolio]

A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer

The purpose of this study is to determine if Ixabepilone combined with carboplatin is better than paclitaxel combined with carboplatin in a subgroup of patients with non-small cell lung ca...

Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

This randomized phase II trial studies paclitaxel, carboplatin, and bevacizumab or paclitaxel, carboplatin, and temsirolimus or ixabepilone, carboplatin, and bevacizumab to see how well th...

Ixabepilone in Combination With Carboplatin in Patients With Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with NSCLC

A Phase II, Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer

The purpose of this clinical research study is to learn if ixabepilone plus cetuximab improves survival when given as 1st line chemotherapy in subjects with metastatic pancreatic cancer co...

Biomarker Study of Blood Samples From Patients With Non-Small Cell Lung Cancer Treated With Carboplatin and Paclitaxel With or Without Bevacizumab

RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment for non-small cell lung cancer may help doctors predict how patients will respond to treatment. ...

PubMed Articles [30955 Associated PubMed Articles listed on BioPortfolio]

Risk of thromboembolism in cisplatin versus carboplatin-treated patients with lung cancer.

Carboplatin is widely used to treat lung cancer in the United States as an alternative to cisplatin. Several studies have demonstrated that cisplatin-based regimen is associated with a high frequency ...

Evaluation of calculating carboplatin dosage in carboplatin-pemetrexed therapy as the first-line therapy for Chinese patients with advanced lung adenocarcinoma.

This study aims to explore the application of actual carboplatin in carboplatin plus pemetrexed regimen as first-line treatment for advanced lung adenocarcinoma, and to determine the recommended dose ...

Carboplatin plus pemetrexed for the elderly incurable chemo-naive nonsquamous non-small cell lung cancer: Meta-analysis.

In some developed countries, a proportion of nonsquamous non-small cell lung cancer (NSq NSCLC) patients are aged over 70 years when they are diagnosed. However, evidence of lung cancer chemotherapy u...

Brief report: Afatinib and cetuximab in four patients with EGFR exon 20 insertion positive advanced non-small-cell lung cancer.

Epidermal growth factor receptor (EGFR) exon 20 insertions comprise 4-9% of EGFR mutated non-small-cell lung cancer (NSCLC). Despite being an oncogenic driver, they are associated with primary resista...

Single Nucleotide Polymorphisms inCorrelate with Lung Cancer Risk in the Northeast Chinese Han Population.

Lung cancer is the principal cause of cancer-associated deaths.has been reported to be associated with tumorigenesis. This study aimed to investigate the relationship between rs1412125 and rs1360485 p...

Medical and Biotech [MESH] Definitions

Tumors or cancer of the LUNG.

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.

An organoplatinum compound that possesses antineoplastic activity.

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.

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.

More From BioPortfolio on "Carboplatin, Ixabepilone, and Cetuximab in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Untreated With Chemotherapy"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...

Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers)  - Mouth cancer can develop on the lip, the tongue, the floor...

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...


Searches Linking to this Trial