Aspirus Regional Cancer Center

Cancer Clinical Trials

This is a current listing of active clinical trials at the Aspirus Regional Cancer Center. From this list you can select a specific cancer that you are interested in (for example, breast or colon cancer) and then review the clinical trials that are active at the Aspirus Regional Cancer Center for that specific disease.

Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Trial Name: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers.

Protocol ID: GOG 3001

Eligibility:

Inclusion

  • Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x6 cycles.   *Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with unknown primary tumor, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded.
  • Subjects with FIGO Stage IIIA or IIIB disease must have undergone primary debulking surgery (PDS) for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to study entry.
  • Subjects with FIGO Stage IIIC or IV disease must either: Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to study entry OR Plan to have interval debulking surgery (IDS) following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer.
  • Must meet required laboratory values

Exclusion

  • Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers other than cytoreductive surgery.
  • Previous abdominal and/or pelvic external beam radiotherapy
  • History of central nervous system metastasis
  • Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor.
  • Prior myeloablative high-dose chemotherapy with allogeneic or autologous stem cell (or bone marrow) transplant.
  • Subjects with a history of prior malignancy, except: Malignancy treated with curative intent and with no known active disease present for > 3 years prior to study entry and felt to be at low risk for recurrence by treating physician, Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease, adequately treated cervical carcinoma in situ without evidence of disease.
  • History of allergic reactions to bacterially-produced proteins
  • Hypersensitivity to paclitaxel or drugs using the vehicle cremophor

Pregnant or is breast feeding or planning to become pregnant within 32 days after the end of treatment

Enrollment: 2000 Patients

Benefits:

No one knows if this study will help you.  Your condition may get better but it could stay the same or even get worse.  The information from this study might help to develop better treatments in the future for epithelial ovarian, primary peritoneal or fallopian tube cancers.

Contact:

These clinical trial overviews are intended to provide a brief overview of the clinical trial. To help determine whether the trial is appropriate for you, the major eligibility criteria are listed above. To obtain more information on the eligibility and the treatment plan, please contact our Oncology Clinical Research Coordinator, Beth Knetter at 715-847-2353 or 1-800-283-2881, ext.72353.

Created: Jan 18, 2013

Updated: Jan 18, 2013

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