SWOG-S0124: A randomized Phase III trial of Cisplatin and Irinotecan versus Cisplatin and Etoposide in patients with extensive stage small cell lung cancer.
Principal Investigator: Robert Gottlieb, MD
Collaborators: Hematology/Oncology Physicians of Lancaster
Sponsor: Southwest Oncology Group
Objectives: To compare the survival of patients with extensive stage small cell lung cancer treated with Cisplatin and Irinotecan versus Cisplatin and Etoposide to compare the progression-free survival, toxicities, and response rate (confirmed plus unconfirmed complete plus partial) in patients with E-SCLC treated with Cisplatin and Irinotecan versus Cisplatin and Etoposide, to assess the association between UGT1A1 polymorphisms and Irinotecan-associated toxicities in patients with E-SCLC and, finally, to assess the association between ERCC-1 and XRCC-1 polymorphisms and non-response to Cisplatin and Irinotecan and to Cisplatin and Etoposide.
SWOG-S9925: Lung cancer specimen repository protocol, ancillary.
Principal Investigator: Robert Gottlieb, MD
Collaborators: Hematology/Oncology Physicians of Lancaster
Sponsor: Southwest Oncology Group
Objective: This protocol is a laboratory companion for Southwest Oncology Group coordinated trials for lung cancer whose objectives are to establish a central lung center specimen repository to serve as a resource for current and future scientific studies, to utilize the Southwest Oncology Group clinical data base to perform clinicopathologic correlation with the results of those studies, and to test new hypotheses as they emerge. Patients must be enrolled in a Southwest Oncology Group coordinated lung cancer treatment protocol. Those individuals found to be ineligible for a therapeutic study will be declared ineligible for this ancillary study, as well. The patients must have adequate diagnostic tissue available, as defined in the protocol, and the establishment of this lung tumor repository is viewed as a long-term ongoing project. The model informed consent for specimen submission will be obtained and documented with consent for the appropriate treatment protocol.
Evaluation of New Guide and Sheath Shapes for the Right-Sided Approach to Biventricular Pacing
Principal Investigator: Seth J. Worley, MD
Collaborators: Douglas C. Gohn, MD
Sponsor: None
Objective: The purpose of this study is to evaluate the performance of guiding catheters and sheaths specifically shaped for right-sided biventricular pacing systems.
Opening of Totally Occluded Axillary/Subclavian/Innominant Veins on the Side of Preexisting Pacemakers or Implantable Cardioverter Defibrillators
Principal Investigator: Seth J. Worley, MD
Collaborators: Douglas C. Gohn, MD
Sponsor: None
Objective: The purpose of the study is to prospectively assess the safety and efficacy of opening totally occluded axillary/subclavian/innominant vein systems on the side of existing pacemaker or ICD systems. The study will utilize a variety of FDA-approved devices in an attempt to cross and open occluded vein systems. Some equipment may be used for a purpose different from that for which it was originally approved. For example, a device labeled for coronary artery use may be used to open the fibrous tract surrounding a pacing lead.
A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Pexelizumab in Patients with Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention (APEX MI)
Principal Investigator: Roy S. Small, MD
Collaborators: The Heart Group
Sponsor: Alexion & Proctor & Gamble Pharmaceuticals
Objective: The study is evaluating the use of adjunctive therapy with a monoclonal antibody that binds to the C5 component of complement to reduce and/or inhibit acute inflammatory reactions for the treatment of patients with acute MI undergoing primary PCI.