SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

2014-08-27 03:56:19 | BioPortfolio


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.

PURPOSE: Randomized phase II trial to study the effectiveness of metastatic or recurrent non-small cell lung cancer.



- 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.

Study Design

Allocation: Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Treatment


Lung Cancer


cBR96-doxorubicin immunoconjugate, docetaxel


Cancer Institute at Oregon Health and Science University
United States


Active, not recruiting


National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:56:19-0400

Clinical Trials [4502 Associated Clinical Trials listed on BioPortfolio]

FDG-PET to Investigate SGN-15 and Docetaxel in Patients With Advanced Non-Small Cell Lung Carcinoma

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...

Docetaxel in Breast Cancer

Primary objective : - To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide foll...

Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

Primary: To determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer Secondary: - Clinical response rate ...

Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide in Axillary Node-Positive Breast Cancer

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...

Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer

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 ...

PubMed Articles [15761 Associated PubMed Articles listed on BioPortfolio]

Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057.

Nivolumab, a programmed death-1 inhibitor, prolonged overall survival and had a favourable safety profile versus docetaxel in previously treated patients with advanced non-squamous non-small cell lung...

Updated efficacy analysis including secondary population results for OAK: a randomized phase III study of atezolizumab vs docetaxel in patients with previously treated advanced non-small cell lung cancer.

The efficacy and safety of atezolizumab vs docetaxel as second- or third-line treatment in patients with advanced non-small cell lung cancer in the primary (n=850; ITT850) and secondary (n=1225; ITT12...

Down-regulation of micro-RNA-1 (miR-1) in lung cancer. Suppression of tumorigenic property of lung cancer cells and their sensitization to doxorubicin-induced apoptosis by miR-1.

Preparation, characterization and in vitro activity of a docetaxel-albumin conjugate.

Docetaxel is one of the most effective anticancer drugs. However, the current formulation of docetaxel contains Tween 80 and ethanol as the solvent, which can cause severe side effects. Consequently, ...

BRIEF REPORT: Association of PALB2 Messenger RNA Expression with platinum-docetaxel efficacy in advanced non-small cell lung cancer.

PALB2, the partner and localizer of BRCA2, is essential for homologous recombination repair. We examined messenger ribonucleic acid (mRNA) levels of DNA-repair genes including PALB2, RNF8, RIF1, ATM, ...

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.

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).

More From BioPortfolio on "SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer"

Quick Search


Relevant Topics

Prostate Cancer
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...

Clincial Trials
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)
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...

Searches Linking to this Trial