Dana-Farber / Brigham and Women's Cancer Center

New Approaches in Clinical Trials for Gynecologic Cancers

Barrett Rollins, MD, PhD, Janina Longtine, MD, Monica Bertagnolli, MD, Philip Kantoff

Ursula A. Matulonis, MD, Medical Director of the Center for Gynecologic Oncology, and Joyce Liu, MD, Medical Oncologist

The Center for Gynecologic Oncology at Dana-Farber/ Brigham and Women’s Cancer Center offers between 15 and 20 open clinical trials at a given time, spanning multiple disciplines – including medical oncology, radiation oncology, and gynecologic oncology.

“Clinical trials are a major focus of our entire team,” said Ursula A. Matulonis, MD, Medical Director of the Center for Gynecologic Oncology. “They serve as a means for us to advance care for patients and offer new treatment options that are not broadly available elsewhere.”

Current trials at the Center include:

  • Phase II trial evaluating cediranib (AZD2171) and olaparib (AZD2281) for ovarian cancer – This randomized phase II study is comparing the combination of cediranib, an anti-angiogenic agent, and olaparib, a PARP inhibitor, to olaparib alone in patients with platinum sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer. For more information, please contact Principal Investigator Joyce Liu, MD, at (617) 632-5269 or joyce_liu@dfci.harvard.edu;
  • Phase Ib/II study of carboplatin/gemcitabine/vorinostsat for platinum-sensitive recurrent ovarian cancer – The objectives of the Phase Ib portion of this study are to assess toxicities of this regimen and to determine a recommended Phase II dose. In the Phase II portion, the trial will determine progression-free survival of this regimen in women with platinum-sensitive recurrent cancer. This trial is offered for patients in their first recurrence of ovarian cancer, peritoneal cancer or fallopian tube cancer with a performance status of 0 or 1 and cancer that is measurable or evaluable via CA125. For more information regarding this trial, please contact Principal Investigator Ursula A. Matulonis, MD, at (617) 632-2334 or umatulonis@partners.org;
  • Phase II study of XL147 for recurrent endometrial cancer – This trial will assess the effectiveness of XL147 as an oral inhibitor of the PI3-kinase pathway, an important pathway in the pathogenesis of endometrial cancer. Offered for patients with recurrent endometrial cancer and a performance status ranging from 0 to 2, this trial is designed to follow at least one prior platinum-based chemotherapy regimen and no more than two prior systemic regimens or any mTOR or other PI3k inhibitor. For more information, please contact Principal Investigator Ursula A. Matulonis, MD, at (617) 632-2334 or umatulonis@partners.org;
  • Phase II study of MK2206 for patients with platinum-sensitive recurrent ovarian cancer, peritoneal cancer and fallopian tube cancer – This study is offered for patients with histology grade 2 or 3 serous cancer and performance status of 0 or 1. Patients should be treated with ≤ 2 lines in the recurrent setting. For more information, please contact Principal Investigator Joyce Liu, MD, at (617) 632-5269 or joyce_liu@dfci.harvard.edu;
  • Phase I dose escalation study of the safety and pharmacokinetics of DMUC5754A for patients with platinum-resistant ovarian cancer, peritoneal cancer and fallopian tube cancer (documented progression via RECIST criteria) – This study is offered for patients with ECOG ≤ 1, serum CA125 ≥ 2x ULN or archival tumor tissue biopsy demonstrating MUC16 expression by central review, and no prior MUC16 targeted therapy. For more information, please contact Principal Investigator Joyce Liu, MD, at (617) 632-5269 or joyce_liu@dfci.harvard.edu;
  • Phase II study of MK2206 for recurrent endometrial cancer – This study is offered for patients with any histology of endometrial cancer (except carcinosarcomas), at least one previous treatment for recurrent cancer is mandated and up to two is permitted, measurable cancer by CT or MRI via RECIST 1.1, no prior PI3kinase inhibitor treatment in the past, and performance status of 0 or 1. For more information, please contact Principal Investigator Andrea Myers, MD, PhD, at (617) 243-6433 or apmyers@partners.org.
Managing Drug Sensitivities and Allergies

Mariana C. Castells, MD, PhD, Director of the Desensitization Program at Dana-Farber/Brigham and Women’s Cancer Center, has developed a comprehensive program that evaluates and cares for all patients with adverse reactions to chemotherapy and monoclonal antibodies, as well as new biological agents. It is the only program nationwide to provide standardized desensitizations with a 12-step protocol.

“Desensitization enables patients to receive and tolerate medications that are most likely to deliver the best outcome,” said Dr. Castells. “Patients can receive multiple desensitizations to complete their required therapy cycle or the participation in clinical studies and can be desensitized to multiple medications.”

With 400 to 500 cases each year, the Desensitization Program provides rapid desensitizations to all patients in need of first-line therapy that has resulted in severe allergic reactions in order to continue treatment. The protocol has been used nationally and internationally to desensitize patients who experience reactions to carboplatin and other platins, taxenes, and rituximab, as well as other monoclonal therapies. Dr. Castells has established Desensitization Programs in Europe and Asia and trains national and international allergists in rapid desensitizations. The Program has received national and international recognition for providing improved survival and increased quality-of-life for cancer patients.

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