Abstract

Breast cancer is the most common cancer among women in the United States. Despite advances in the early detection and treatment of breast cancer, it remains the second most common cause of cancer death among women. Treatment of metastatic (Stage IV) breast cancer remains palliative, and new treatments are urgently needed. Paclitaxel is one of the most single active agents in the treatment of metastatic breast cancer, with reponse rates of over 50% in some Phase II trials. Losoxantrone is an investigational anthrapyrazole DNA intercalating anticancer agent which is in Phase III clinical trials, and has shown response rates up to 45% in Phase II trials in patients with metastatic breast cancer. The current study is an industry sponsored, multicenter, randomized, open-label comparative study between paclitaxel alone vs. the combination of paclitaxel and losozantrone, with G-C SF support in order to maintain drug dose intensity and improve the safety profile. Patients will be randomized in a ratio of 1:2 to paclitaxel alone vs. losozantrone/palitaxel/G-C SF. A total of 300 patients is planned to be entered at approximately 50 sites.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000073-35
Application #
6246352
Study Section
Project Start
1997-01-06
Project End
1997-11-30
Budget Start
1996-10-01
Budget End
1997-09-30
Support Year
35
Fiscal Year
1997
Total Cost
Indirect Cost

  Institution

Name
University of Texas Medical Br Galveston
Department
Type
DUNS #
041367053
City
Galveston
State
TX
Country
United States
Zip Code
77555

  Publications

Gelman, Benjamin B; Endsley, Janice; Kolson, Dennis (2018) When do models of NeuroAIDS faithfully imitate ""the real thing""? J Neurovirol 24:146-155
Mourtakos, S P; Tambalis, K D; Panagiotakos, D B et al. (2017) Association between gestational weight gain and risk of obesity in preadolescence: a longitudinal study (1997-2007) of 5125 children in Greece. J Hum Nutr Diet 30:51-58
Ramanujam, V-M S; Nayeem, Fatima; Anderson, Karl E et al. (2017) Riboflavin as an independent and accurate biomarker for adherence in a randomized double-blind and placebo-controlled clinical trial. Biomarkers 22:508-516
Laffer, Cheryl L; Scott 3rd, Robert C; Titze, Jens M et al. (2016) Hemodynamics and Salt-and-Water Balance Link Sodium Storage and Vascular Dysfunction in Salt-Sensitive Subjects. Hypertension 68:195-203
Hosoki, Koa; Ying, Sun; Corrigan, Christopher et al. (2015) Analysis of a Panel of 48 Cytokines in BAL Fluids Specifically Identifies IL-8 Levels as the Only Cytokine that Distinguishes Controlled Asthma from Uncontrolled Asthma, and Correlates Inversely with FEV1. PLoS One 10:e0126035
Murai, Hiroki; Okazaki, Shintaro; Hayashi, Hisako et al. (2015) Alternaria extract activates autophagy that induces IL-18 release from airway epithelial cells. Biochem Biophys Res Commun 464:969-974
Diaz, Eva C; Herndon, David N; Porter, Craig et al. (2015) Effects of pharmacological interventions on muscle protein synthesis and breakdown in recovery from burns. Burns 41:649-57
Tuvdendorj, Demidmaa; Chinkes, David L; Bahadorani, John et al. (2014) Comparison of bolus injection and constant infusion methods for measuring muscle protein fractional synthesis rate in humans. Metabolism 63:1562-7
Sallam, Hanaa S; McNearney, Terry A; Chen, Jiande D Z (2014) Acupuncture-based modalities: novel alternative approaches in the treatment of gastrointestinal dysmotility in patients with systemic sclerosis. Explore (NY) 10:44-52
Petersen, John R; Stevenson, Heather L; Kasturi, Krishna S et al. (2014) Evaluation of the aspartate aminotransferase/platelet ratio index and enhanced liver fibrosis tests to detect significant fibrosis due to chronic hepatitis C. J Clin Gastroenterol 48:370-6

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