The Gillette Center for Gynecologic Oncology has become one of the nation's outstanding centers for clinical research in gynecologic malignancy. The center has had a strong leadership role at every level of development of therapies for women's cancers, whether it is in pre-clinical drug development, Phase I and II trials, or Phase III cooperative clinical trials.

Collaborative clinical research is carried out within the Harvard system with the collaboration among the divisions of Gynecologic Oncology within the cancer centers of Massachusetts General Hospital, Brigham and Women’s Hospital, Dana Farber Cancer Center, and the Beth Israel Deaconess Medical Center. Beyond Harvard, collaborative clinical trials are conducted nationally in association with the Gynecologic Oncology Group.

Ovarian Cancer
Studies of new means of detecting ovarian cancer, understanding the genetic processes in ovarian carcinomatosis, imaging residual cancer in the peritoneal cavity after completion of therapy, and development of biologic therapy for ovarian cancer form the basis for new treatments still in the pipeline. Collaboration with industry has permitted access to experimental therapies and phase I and II trials, while novel combinations of drugs designed to confound development of drug resistance are in continuing trials for primary post surgical therapy of epithelial ovarian neoplasms. The center has expanded its clinical capabilities in surgical management of this disease and its recurrence concurrently with the development of new first-line therapies and drugs for the management of recurrent disease.

With the support of OCEAN (Ovarian Cancer Education and Awareness Network), a comprehensive serum and tumor bank for ovarian cancer provides broad-based support for both pre clinical and clinical investigators seeking new diagnostic and therapeutic interventions, as well as a better understanding of the molecular and biologic nature of this disease. This extensive resource is linked with anonymous clinical histories in a manner that permits correlation of laboratory findings with the clinical behavior of disease and its treatment, yet safeguards the privacy of patients. In addition, with the support of the Vincent Obstetrics and Gynecology Service and the Vincent Center for Reproductive Biology the MGH GYN Tissue Repository has been expanded to include the collection of discarded benign and malignant endometrial and cervical tissue, corresponding serum and applicable clinical information. The expanded tissue repository is expected to compliment our growing focus on translational research spearheaded by an active group of the department’s clinical fellows, clinicians and basic scientists.

Endometrial Cancer
Earlier research in the Gillette Center for Gynecologic Oncology demonstrated the prolongation of disease-free survival with cytoreductive surgery for widely metastatic endometrial cancer. Current research builds upon this experience with further retrospective studies of the natural history of treated disease and prospective trials of novel combinations of conventional chemotherapeutic agents. Similarly, studies of the molecular pathogenesis of this disease will be facilitated by expansion of our tumor-banking program.

Cervical Cancer
Cervical cancer is largely preventable through proper screening and therapy of pre malignant disease. Yet it is the leading cause of death among women in a large number of developing countries. Clinical research in this disease extends from investigation of the barriers that prevent women from getting access to screening and early therapy to clinical trials of combination chemotherapy for advanced metastatic and recurrent carcinoma. Development of combination chemotherapy with enhanced response rates and decreased toxicity remain a continued goal of this clinical research.

Quality-of-life Therapies
Should enhanced response to treatments of cancer always come at the price of increased toxicity? What motivates patients to seek clinical trials at the beginning and end of cancer treatment? How should physicians communicate risk and benefits to patients when discussing clinical trials? These are a few of many questions being studied in clinical trials in the Gillette Center for Gynecologic Oncology. The center continues to expand dramatically with increased recruitment of physicians and nurse practitioners dedicated to methodically improving patients' lives, working collaboratively with research staff and basic scientists to pursue an enlightened course in bringing translational research to clinical reality.

The Role of Alternative and Complementary Therapy in Cancer care
Several Studies have evaluated acupuncture therapy for women with advanced ovarian cancer. One study looked at the improvement of quality of life. A second randomized, single blind study evaluated the effect of acupuncture on white blood cell counts during chemotherapy. Currently at the Massachusetts General Hospital, the Strength and Serenity Center, a virtual center committed to the education of patients, families, and healthcare providers, is developing a clearing House of the world’s literature on Alternative and Complementary Therapy in cancer care. 

Selected Clinical Research Protocols

Tumor Banking for Patients with Rare Tumors, Ovarian Tumors and Recurrent Tumors, Ascites and Blood Collection

Phase I Safety,PK/PDStudy of PXD101 in combination with Paclitaxel &Carboplatin for solid tumors with no curative therapy

Survivorship in early-stage ovarian cancer

A Randomized Phase II Trial of Avastin (A) or Avastin and Erlotinib (AE) as First Line Consolidation Chemotherapy after Carboplatin, Paclitaxel and Avastin Induction Therapy(CTA) for Newly Diagnosed Advanced Ovarian, Fallopian Tube, Primary Peritoneal Cancer & Papillary Serous Mullerian Tumors

Phase II Study of Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer

A Randomized, Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy

A Phase II, Single-Arm Study of Volociximab Monotherapy in Subjects With Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer

An Open-Label, Single-Arm, Phase II Safety and Tolerability Study of Catumaxomab (Anti-EpCAM x anti-CD3) in Women with Advanced Epithelial Ovarian Cancer after a Complete Response to Chemotherapy

A Phase II Open-Label, Multi-Center Study of SNS-595 Injection in Patients with Platinum Resistant Ovarian Cancer

A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

A Phase II Study of AZD2171 in Subjects with Recurrent Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer

A single-arm, open-label, Phase II study to assess the safety and efficacy of the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) administered intraperitoneally in ovarian cancer patients with recurrent symptomatic malignant ascites

A Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of Pertuzumab (rhuMAb 2C4) in Combination with Gemcitabine and the Effect of Tumor Based HER2 Activation in Subjects with Platinum- Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis +/- chemotherapy for Post-operative Patients with either Endometrial or Cervical Carcinoma

A Phase II pilot investigation of the relationship of short term depo-provera (medroxyprogesterone acetate) exposure to the morphologic, biochemical, and molecular changes in primary endometrioid adenocarcinoma of the uterine corpus.

Understanding Barriers to Cervical Cancer Screening Among Latino Woman in Boston

A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis +/- chemotherapy for Post-operative Patients with either Endometrial or Cervical Carcinoma

A Phase II Trial of Tarceva (erlotinib) in Women with Squamous Cell Carcinoma of the Vulvar

Faculty
Annekathryn Goodman, MD
Interim Chief, Division of Gynecologic Oncology
Marcela del Carmen, MD, MPH
Clinical Director
Bo R. Rueda, PhD
Director of MGH GYN Tissue Repository
Carolyn N. Krasner, MD
Chair, Gynecologic Oncology Research Committee

Debra A. Bell, MD
Linda R. Duska, MD
John Eichorn, MD
Tayyaba Hasan, PhD
Esther Oliva, MD
Sandra Orsulic, PhD
Richard T. Penson, MD
Anthony H. Russell, MD
Robert H. Young, MD

Selected Publications
Berkenblit A, Seiden MV, Matulonis UA, Penson RT, Krasner CN, Lisa Mezzetti, Tina Atkinson and Stephen A. Cannistra. A Phase II trial of weekly docetaxel in patients with platinum-resistant epithelial ovarian, primary peritoneal serous cancer, or fallopian tube cancer Gynecol Oncol Volume 95, Issue 3, December 2004: 624-631.

Fleming GF, Brunetto VL, Cella D, Look KY, Reid GC, Munkarah AR, Kline R, Burger RA, Goodman A, Burks RT. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: A Gynecologic Oncology Group study.  J Clin Oncol 2004; 22:2159-2166.

Ryan DP, Eder JP Jr, Puchlaski T, Seiden MV, Lynch TJ, Fuchs CS, Amrein PC, Sonnichsen D, Supko JG, Clark JW. Phase I clinical trial of the farnesyltransferase inhibitor BMS 214662 given as a one hour intravenous infusion in patients with advanced solid tumors. Clinical Cancer Research Vol. 10, April 2004: 2222-2230.

Penson RT, Oliva E, Skates SJ, Glyptis T, Fuller AF, Goodman A, Seiden MV. Expression of multidrug resistance-1 protein inversely correlates with paclitaxel response and survival in ovarian cancer patients: a study in serial samples. Gynecol Oncol. 2004; 93:98-106.

Penson RT, Seiden MV, Goodman A, Fuller AFF, Berkowitz RS, Matulonis UA, Krasner C, Lee H, Atkinson T, Campos SM. Phase I trial of escalating doses of toptecan in combination with a fixed dose of pegylated liposomal doxorubicn in women with mullerian malignancies. Gynecol Oncol 2004; 93:702-707.

Seiden MV, Muggia F, Astrow A, Matulonis U, Campos S, Roche M, Sivret J, Rusk J and Emma Barrett. A phase II study of liposomal lurtotecan (OSI-211) in patients with topotecan resistant ovarian cancer. Gynecol Oncol Volume 93, Issue 1, April 2004:229-232.

Duan Z, Brakora KA, and Seiden MV. Inhibition of ABCB1 (MDR1) and ABCB4 (MDR3) expression by small interfering RNA and reversal of paclitaxel resistance in human ovarian cancer cells Mol Cancer Ther. 2004;3:833-838.