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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
- Determine the progression-free survival of patients with extensive-stage small cell lung cancer treated with CCI-779.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to brain metastases (yes vs no), prior induction chemotherapy regimen (platinum and etoposide vs platinum and irinotecan), and response to prior induction chemotherapy (complete or partial response vs stable disease). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive low-dose CCI-779 IV over 30 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive high-dose CCI-779 as in arm I. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 2.7-3.2 years.
Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment
CCOP - Colorado Cancer Research Program, Incorporated
Eastern Cooperative Oncology Group
Published on BioPortfolio: 2014-08-27T03:56:27-0400
This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination thera...
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of the combination of temsirolimus and pemetrexed, as well as the response rate.
This study is being done to determine the highest safe dose of the combination of temsirolimus and axitinib; to learn the side effects when these drugs are given together; and to determine...
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In this study, the investigational drug, temsirolimus, will be combined with cetuximab, a biologic agent used in the treatment of colorectal cancer. Cetuximab in combination with temsirol...
Lung cancer is one of the deadliest malignancies. The immune checkpoint-blockade (ICB) tumor therapy has led to striking improvement of long-term survival for some lung cancer patients. However, the r...
Recent studies have indicated that microRNAs (miRNAs) are closely related to lung cancer. However, the effects of miR-1246 on lung cancer are still elusive. In this study, we aimed to explore the mole...
Compared with all other racial and ethnic groups in the U.S., African Americans are disproportionally affected by lung cancer, both in terms of incidence and survival. It is likely that smoking, as th...
The exploration of the molecular mechanisms and signaling pathways on lung cancer is very important for developing new strategies of diagnosis and treatment to this disease, such as finding valuable l...
Chronic inflammation has been implicated in carcinogenesis, with increasing evidence of its role in lung cancer. We aim to evaluate the role of genetic polymorphisms in inflammation-related genes in t...
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.
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.
A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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