EORTC opens trial for patients with high grade undifferentiated uterine sarcoma, a rare cancer

Uterine sarcomas account for just 1% of female genital tract cancers. The aggressive character of these sarcomas is well known, but because they are both rare and diverse, consensus concerning appropriate treatment has not been reached. Outcome for these patients is poor.

Cabozantinib is an oral tyrosine kinase inhibitor approved for the treatment of metastatic medullary thyroid cancer and is also being investigated in several clinical trials for patients with prostate, ovarian, brain, melanoma, breast, lung, liver and kidney cancers. It is thought that this pharmaceutical could also be a beneficial maintenance treatment after chemotherapy for patients with sarcoma, because it blocks important pathways in the tumor growth process.

EORTC trial 62113 – 55115 plans to assess the efficacy of maintenance treatment with cabozantinib after stabilization or response to chemotherapy following surgery for locally advanced or in first line metastatic disease in patients with high grade undifferentiated uterine sarcoma. The objective of this trial is to detect an improvement in progression-free survival at 4 months and eventually an improvement in overall survival by adding maintenance treatment.

Prof. Isabelle Ray Coquard of the Centre Leon Berard in Lyon and coordinator of this study says, “Registration and randomization for this trial will occur in two stages. In the first stage, we anticipate registering 78 patients with high grade undifferentiated uterine sarcoma, and these patients will receive first line chemotherapy. When this first line treatment is completed, 54 patients whose cancer has not progressed will be randomized to receive either cabozantinib monotherapy or placebo. Patients receiving placebo can receive cabozantinib if their disease progresses.”

Intergroup EORTC trial 62113-55115 is coordinated by the EORTC Soft Tissue and Bone Sarcoma and Gynecological Cancer Groups. This trial is part of the International Rare Cancers Initiative, IRCI, put forth by the National Institute for Health Research Cancer Research Network, Cancer Research UK, the United States National Cancer Institute, and the EORTC. IRCI facilitates the development of international clinical trials for patients with rare cancers to boost the progress of new treatments for these patients. The EORTC Groups will conduct this randomized phase II trial in 17 sites in six countries: Belgium, France, Germany, Italy, Spain, and The Netherlands. This is an academic trial supported by the EORTC Soft Tissue and Bone Sarcoma Group, the EORTC Gynecological Cancer Group, and a restricted educational grant from Exelixis, who supply cabozantinib, the investigational drug.

For more information concerning EORTC trial 62113-55115 please contact: www.eortc.org/contact

John Bean, PhD
EORTC, Medical Science Writer