Moffitt Cancer Center Recognizes Ovarian Cancer Awareness Month

September 14, 2009

Tampa, FL – September is Ovarian Cancer Awareness Month. Ovarian cancer is the leading cause of death from gynecologic cancers in the United States. Unfortunately, many times there are few early warning signs. Moffitt Cancer Center offers several resources and clinical trials available to patients suffering from the disease or who think they might have the disease.                

The Center for Women’s Oncology:

Designed to integrate clinical, research and teaching activities that focus on breast and gynecologic cancers in particular, the center provides:

            * Outpatient clinic visits with gynecologic oncologists, breast surgeons, medical oncologists, radiation             oncologists, psychologists and other professionals for patients with breast or gynecologic cancers

            * Imaging services, including mammography, ultrasound and MRI

            * Genetics counseling and testing

            * Diagnostic procedures, including breast biopsies and colposcopy

            * Cancer screening, prevention and early detection services

            * Survivorship programs

            * Complementary/integrative medicine programs including acupuncture, yoga and massage

The center integrates interdisciplinary expertise with services that are customer friendly and efficient. Every physician affiliated with the center is fellowship trained, bringing advanced expertise to women’s cancer care. Experts in gynecologic cancers include:

*Johnathan M. Lancaster, M.D., Ph.D., director of The Center for Women’s Oncology

            *Sachin M. Apte, M.D., M.S., assistant member of Gynecologic Oncology

            *William S. Roberts, M.D., senior member of Gynecologic Oncology

*Robert M. Wenham, M.D., M.S., FACOG, assistant member of Gynecologic Oncology

In addition, the center exemplifies the concept of personalized medicine, an approach that identifies genetic and biological markers that detect cancer, predict risk or point to specific interventions for a particular patient by finding genetic “signatures” that could indicate best response to treatment.

Clinical Trials:

Overview of Moffitt’s Clinical Trials for Women with Ovarian Cancer

Informed decisions about treatment should include consideration of the standard of care, as well as current clinical trials, in which new agents that have shown promise in earlier studies are being investigated. Early knowledge of clinical trials can reduce risk for a missed opportunity to be screened for participation in an appropriate treatment study. To increase awareness about the gynecologic oncology clinical trials that are available to women with ovarian cancer, we are providing the following information: study title, identification number, a brief description of its purpose, and a few of the major eligibility criteria. (Note: If you have questions about studies 1-5, call Sierra Theodore, RN, CCRC, (813) 745-7272. If you have questions about studies 6-8, call Luz Diez, RN, BSN, (813) 745-4625.)

  1. Phase II using BAY 43-9006 (Sorafenib) and Paclitaxel/Carboplatin in women with recurrent platinum sensitive epithelial, ovarian, peritoneal or fallopian tube cancer. (MCC# 14889)

      The purpose of this study is to evaluate a new drug, Sorafenib, in combination with     Carboplatin and Paclitaxel, both of which have been approved by the Food and Drug          Administration and are standard treatments for women with ovarian, fallopian tube or            peritoneal cancer.

      Among the eligibility requirements that the study nurse would discuss are:

  • Measurable disease must be evident on a CT scan.
  • At least six months must have passed since prior platinum therapy.
  • A prospective participant cannot have had more than two prior chemotherapy regimens.
  1. A Pilot Trial of Genomic Directed Salvage Chemotherapy with either Liposomal Doxorubicin or Topotecan in Recurrent or Persistent Ovarian Cancer. (MCC# 15042)

      The purpose of this study is to determine the success of using a special technique,        called “microarray technology,” to examine cancer genes to predict how a woman        will respond to one of two therapies, and which might be more effective in treating     ovarian cancer that has recurred.

      Among the eligibility requirements that the study nurse would discuss are:

  • The recurrence must have happened within 12 months of prior platinum            chemotherapy.
  • Disease must be measurable and able to be biopsied.
  • A prospective participant cannot have had more than two prior chemotherapy regimens.
  1. A Randomized, Double-Blind, Placebo Controlled, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against (Igf-1r) to FIRST LINE Chemotherapy In Patients With Optimally Debulked Epithelial Ovarian Cancer. (MCC# 15686)

      The purpose of this study is to test a new anticancer drug, AMG 479, which targets a receptor of the tumor, and compare the effectiveness and safety of the different           treatments.

      Among the eligibility requirements that the study nurse would discuss are:

  • Consent must be obtained PRIOR to initial surgery.
  • Patients must have had optimally debulked (less than 1 cm of cancer after surgery for stages III or IV) cancer.
  • No prior treatments for ovarian cancer can have been given.

4. Multicenter, Randomized, Double-Blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination with Carboplatin and Paclitaxel Compared to Placebo plus Carboplatin and Paclitaxel in Patients with Advanced Ovarian Cancer. (MCC# forthcoming)

      The purpose of this study is to test whether the study drug, BIBF 1120, with the         standard combination chemotherapy (Paclitaxel and Carboplatin) is more effective in        prolonging progression-free survival than the standard chemotherapy alone.

      Among the eligibility requirements that the study nurse would discuss are:

  • This must be a first diagnosis of ovarian, fallopian tube or primary peritoneal cancer.
  • The cancer may have been optimally (less than 1 cm of remaining tumor) or      suboptimally debulked (more than 1 cm of remaining tumor).

5. A Pilot Program to Personalize Care by Integrating Traditional and Complementary Medicine for Women with Recurrent Ovarian Cancer. (MCC 15221)

      The purpose of this study is to find out if complementary and alternative medicine      (CAM) should be included with traditional therapy for women with recurrent ovarian             cancer. Some of the alternative medicines include herbal therapies and dietary and   nutritional strategies and yoga and meditation. Only a few of these alternative          medicines have been tested in women with ovarian cancer. This study will assess the       interest level for various CAM topics, assess the effects of integrating them into          regular care, and analyze whether the data support a recommendation for a larger       CAM program.

      Among the eligibility requirements that the study nurse would discuss are:

  • A participant must have a diagnosis of recurrent ovarian cancer.
  • Women must be willing to complete multiple questionnaires, participate in two             telephone interviews, and attend four educational integrative medicine sessions at       Moffitt.

6. A Phase I Trial Of A SRC Kinase Inhibitor, Dasatinib, In Combination With Paclitaxel And Carboplatin In Patients With Advanced Or Recurrent Ovarian, Peritoneal, And Tubal Cancer (MCC 15041)

      The purpose of this study is to improve the treatment for ovarian cancer and to            determine the highest dose of dasatinib that can be given safely when used with            paclitaxel and carboplatin, as well as the types and severity of side effects that may be    caused by the investigational drug, dasatinib.

      Among the eligibility requirements that the study nurse would discuss are:

  • A participant must have advanced or recurrent ovarian, peritoneal or tubal cancer.
  • The patient’s disease must be measurable.
  • She may have had up to three prior chemotherapy regimens.

7. Phase 1b Study of AMG 386 in Combination with Either Pegylated Liposomal Doxorubicin or Topotecan in Subjects with Advanced Recurrent Epithelial Ovarian Cancer (MCC 15707)

      The purpose of this study is to evaluate the effectiveness, tolerability and safety of      AMG 386 when used with pegylated liposomal doxorubicin or Topotecan in subjects    with advanced recurrent epithelial ovarian, fallopian tube or primary peritoneal       cancer. AMG 386 is a man-made drug that is designed to stop the development of      blood vessels in cancer tissues. Cancer tissues rely on the development of new blood   vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

      Among the eligibility requirements that the study nurse would discuss are:

  • A participant must have recurrent, invasive ovarian, tubal or peritoneal cancer.
  • The patient cannot have had more than three previous regimens of anticancer therapy.
  • The patient must have received at least one platinum-containing regimen.

8. A Phase Ia Study of MK-4827 in Patients with Advanced Solid Tumors and Phase Ib Study in Patients with BRCA Mutant Ovarian Cancer (MCC 15606)

The purpose of this study is to test the safety of the research study drug, MK-4827, see how a person responds, find the highest dose of MK-4827 that can be given      safely without serious side effects, and find out how the body absorbs and breaks     down MK-4827. MK-4827 is an investigational drug, which is being tested and is not approved for sale in the United States by the FDA.

            Among the eligibility requirements that the study nurse would discuss are:

  • For Phase Ib, a woman must have a confirmed locally advanced or metastatic solid tumor with documented BRCA1 or BRCA2 mutation, for which there is no standard therapy or the patient has refused standard treatment.

About H. Lee Moffitt Cancer Center & Research Institute

Located in Tampa, Florida, Moffitt Cancer Center  is an NCI Comprehensive Cancer Center - a designation that recognizes Moffitt’s excellence in research and contributions to clinical trials, prevention and cancer control. Moffitt currently has 15 affiliates in Florida, one in Georgia and two in Puerto Rico. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country’s leading cancer centers, and is listed in U.S. News & World Report as one of “America’s Best Hospitals” for cancer. Moffitt’s sole mission is to contribute to the prevention and cure of cancer.

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