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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...
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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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