Track topics on Twitter Track topics that are important to you
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. SGN-15 may be able to locate tumor cells and kill them without harming normal cells. Combining SGN-15 with docetaxel may kill more tumor cells.
- Determine the toxicity and safety profile of SGN-15 (cBR96-doxorubicin immunoconjugate) in combination with docetaxel in patients with advanced or recurrent non-small cell lung carcinoma.
- Determine the clinical response rate and response duration in patients treated with this regimen.
- Determine the progression-free survival and overall survival of patients treated with this regimen.
OUTLINE: This is a randomized, open-label study. Patients are stratified according to gender and performance status. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive SGN-15 (cBR96-doxorubicin immunoconjugate) IV over 2 hours followed by docetaxel IV over 30 minutes once weekly on weeks 1-3 and 5-7.
- Arm II: Patients receive docetaxel as in arm I. Quality of life is assessed at baseline and on day 1 of each course.
Patients are followed at 8 weeks.
PROJECTED ACCRUAL: A total of 60 patients (40 in arm I and 20 in arm II) will be accrued for this study within 18-24 months.
Allocation: Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Treatment
cBR96-doxorubicin immunoconjugate, docetaxel
Cancer Institute at Oregon Health and Science University
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:56:19-0400
This is an open-label, randomized phase II trial of a monoclonal antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly docetaxel. The primary objecti...
Primary objective : - To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide foll...
Primary: To determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer Secondary: - Clinical response rate ...
This study will determine if docetaxel will be administered before or after doxorubicin/cyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a subsequent phase III tria...
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the ...
The purposes of this study were to investigate the incidence of lymphedema in patients with breast cancer during and after adjuvant treatment with docetaxel, doxorubicin, and cyclophosphamide (TAC), t...
Efficacy and Safety of Ramucirumab With Docetaxel Versus Placebo With Docetaxel as Second-Line Treatment of Advanced Non-Small-Cell Lung Cancer: A Subgroup Analysis According to Patient Age in the REVEL Trial.
Ramucirumab, a recombinant human immunoglobulin G1 monoclonal antibody receptor antagonist designed to block the ligand-binding site of vascular endothelial growth factor receptor-2 (VEGFR-2), was eva...
The approval of injectable generic drugs does not require bioequivalence testing. However, although generic products contain the same level of the active compound, the levels and types of additives pr...
Chemotherapy remains a viable option for the management of advanced non-small-cell lung cancer (NSCLC) despite recent advances in molecular targeted therapy and immunotherapy. We evaluated the efficac...
A randomised phase II trial of docetaxel versus docetaxel plus carboplatin in patients with castration-resistant prostate cancer who have progressed after response to prior docetaxel chemotherapy: The RECARDO trial.
Docetaxel is standard first-line chemotherapy for patients with metastatic castration-resistant prostate carcinoma (mCRPC). Docetaxel re-challenge has never been tested in a prospective randomised con...
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).
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...
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...
GILOTRIF (afatinib) is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L8...