Women's Cancer Research Foundation

Q: What is a clinical trial?

A: Clinical trials are research studies that investigate the safety and efficacy of a specific health intervention (e.g. medications, medical devices, treatment protocol). In cancer research, clinical trials are designed to answer many questions about new and different ways to:

• Treat cancer
• Identify and diagnose cancer
• Prevent cancer
• Manage symptoms of cancer

Q: How do I enter a clinical trial?  What are the criteria?

A: Clinical trials require patients to meet certain criteria. essentially, criteria help to ensure that the people on the trial are similar as possible. This allows doctors greater assurance that the results are due to the treatment being studied and not additional factors. Some common criteria for entering a trial might include:

• Having a certain type and/or stage of cancer
• Having received a specific treatment in the past
• Having had a certain number of previous treatments or therapies

Women’s Cancer Research Foundation (WCRF) Clinical Trials

The Women’s Cancer Research Foundation (WCRF) is dedicated to the study of novel and promising treatments for gynecologic and breast cancers through clinical trial participation and providing these patients with access to treatment. We strive to find the newest and most effective cancer treatments, promptly establish a protocol for our patients and obtain the medications so that our patients have access to them. In the past 11 years, the WCRF has developed collaborative relationships with prominent pharmaceutical and biotech companies, namely Merck, Amgen, Eli Lilly, Genentech-Roche, Pfizer, Endocyte, Centocor Ortho Biotech, Nektar Therapeutics, Abbott Laboratories, and Sunesis Pharmaceuticals, Inc.

WCRF Clinical trials currently open to enrollment or under review:

Pfizer’s Neratinib - Patients With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer.  Must Have Previously Received Trastuzumab and Must Start on Study Drug no Later Than (1) One Year After Last Administration of Trastuzumab.

Merck’s Vorinostat - Newly Diagnosed Ovarian, Primary Peritoneal and  Fallopian Tube Cancer. Stage III-IV and Must Have Not Received Any Prior Chemo Therapies For This Cancer.

Nektar’s Pegylated-Irinotecan - Recurrent ovarian, primary peritoneal and fallopian tube cancers.  No prior treatment with Topotecan, must have received prior Doxil and must be refractory or resistant to Carboplatin.  CT scan must show disease greater than or equal to 1cm.

Morphotek – A randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinum Sensitive Ovarian Cancer in First Relapse

GOA-WP3C – A phase II Open- Label, Non-Randomized, Multi-Center Study of Weekly Paclitaxel and every 3 week Carboplatin for the Treatment of Primary Epithelial Ovarian, Fallopian Tube, Peritoneal or Malignant Peritoneal Mesothelioma

Sanofi-Aventis (XL147) - Advanced or recurrent Endometrial/Uterine carcinoma. May have previously been treated with radiation and/or chemotherapy.  Patient CT scans must demonstrate disease greater or equal to 1 cm.

Genentech-A multi-center, phase II  single arm, open label study of GDC-0980 for the treatment of recurrent or persistent endometrial carcinoma

Abbott – A Trial of ABT-888 in Combination With Temozolomide Versus Pegylated Liposomal Doxorubicin Alone in Recurrent Ovarian Cancer

Radiation Therapy Oncology Group (RTOG)-Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy

Amgen – A randomized, Double-blind, Placebo-Controlled, Phase 2 Trial of Paclitaxel in Combination with AMG 386 in Subjects with Advanced, Recurrent Epithelial Ovarian or Primary Peritoneal Cancer

Vermillion, Inc.-  Marker Discovery and Clinical Trial Testing for OVA2 using Serum from Women with a Documented Ovarian Adnexal Mass

Genentech - A phase III, Multicenter, Randomized, Blinded, Placebo Controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients with Platinum Sensitive Recurrent Ovary, Primary Peritoneal, Or Fallopian Tube Carcinoma

Merck – Phase IV Randomized, Double-Blinded, Multi-Center Study Comparing the Efficacy of Fosaprepitant with Standard Pre-Medicaitons to Aprepitant with Standard Pre-Medications for Chemotherapy Induced Nausea and Vomiting in Patients Treated for Gynecologic Cancer

If you have questions regarding your eligibility for a clinical trial protocol please contact Katrina Lopez, Research Director at the Women’s Cancer Research Foundation.