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January 2012: Trials in Progress

Published: Wednesday, Feb 01, 2012
The Trials in Progress section is intended to stimulate discussion about ongoing clinical trials and to promote collaboration across the oncology community. Each month, OBTN will present summaries of ongoing research in a broad range of cancer types.

Gastrointestinal Cancer

Investigating relationship between plasma platinum levels and neurotoxicity in GI cancer patients receiving oxaliplatin therapy

French researchers are recruiting for a phase IV toxicity study in patients with gastrointestinal (GI) cancer who are taking oxaliplatin. Patients who are receiving or plan to receive oxaliplatin will be eligible for enrollment in this multicenter, open-label trial. Patients must have no pre-existing neuropathy, central nervous system disease, or cerebral metastases when enrolled. During the study, the patient’s neurological function and plasma levels will be measured at baseline after each treatment with oxaliplatin (2-hr IV infusions every 2-3 wk), and at the end of study treatment. The primary endpoint is to determine the relationship between plasma levels of residual platinum with persistent neurotoxicity in the hope that this information will help clinicians plan treatment and improve the quality of life of these patients. The secondary endpoint is to determine the pharmacokinetics of oxaliplatin in patients with GI cancer. The estimated enrollment is 58 patients.

Sponsor: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

ClinicalTrials.gov Identifier: NCT00274885


Head and Neck Cancer

Using lyophilized black raspberries to prevent oral cancer

Ohio State University researchers are trying to determine the best method to administer lyophilized black raspberries as prophylaxis to patients who are at high-risk for oral cancer. The use of lyophilized black raspberries may prevent oral cancer in those with previously diagnosed stage I-IV or in situ head and neck cancer. In this phase I/II trial, there will be 2 treatment arms and 2 placebo arms. Patients will be randomized to (1) placebo lozenge or lyophilized raspberry lozenge; or (2) saliva substitute placebo or lyophilized black raspberry saliva substitute. Treatment will continue for 6 months. Primary objectives are to define safety and tolerability of long-term black raspberry administration after surgery in patients with head and neck cancer, to determine the best dose and delivery vehicle, and to correlate gene expression changes within regulatory pathways and dose and delivery method. The estimated enrollment is 140 patients.

Sponsor: Ohio State University Comprehensive Cancer Center, National Cancer Institute

ClinicalTrials.gov Identifier: NCT01469429


Hematologic Cancer

Fludarabine and busulfan with or without clofarabine for AML and MDS patients that need stem cell transplant

Researchers at MD Anderson Cancer Center are actively recruiting for a new phase III study of 2 combination therapies in patients aged 3 to 70 years with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who also must undergo stem cell transplantation. AML patients in any stage and cytogenetic risk group who have not achieved complete remission with 1 course of induction therapy, and MDS patients with intermediate or high-risk IPSS score or treatmentrelated MDS are eligible for the trial. Some other low-risk MDS patients might be eligible. In this open-labeled trial, patients will be randomized to 1 of 2 arms. Arm 1 will receive busulfan, fludarabine, and clofarabine before stem cell transplantation. Arm 2 will receive busulfan and fludarabine before stem cell transplantation. Patients in both arms will also receive treatment to prevent graft-versushost disease. Patients will be followed quarterly for 5 years after treatment. The primary endpoint is progression-free survival, and the secondary endpoint is overall survival. The researchers will also review safety data of this combination therapy. The estimated enrollment is 250 patients.

Sponsor: MD Anderson Cancer Center

ClinicalTrials.gov Identifier: NCT01471444


Brentuximab vedotin and combination chemotherapy for treating older patients with Hodgkin lymphoma


View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: Bridging the Gaps Around Oncology Biosimilars: Assessing the Potential Impact of Emerging Agents to PracticeSep 29, 20181.5
Community Practice Connections: Oncology Best Practice™ Targeting Cell Cycle Progression: The Latest Advances on CDK4/6 Inhibition in Metastatic Breast CancerOct 31, 20181.0
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