Clinical Trial: Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase III Clinical Trial of Bevacizumab With IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

Brief Summary: This randomized phase III trial studies bevacizumab and intravenous (given into a vein) chemotherapy to see how well they work compared with bevacizumab and intraperitoneal (given into the abdominal cavity) chemotherapy in treating patients with stage II-III ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bevacizumab together with intravenous chemotherapy is more effective than giving bevacizumab together with intraperitoneal chemotherapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine if one or both of the proposed intraperitoneal chemotherapy regimens improves the progression-free survival (PFS) event rate compared to standard intravenous chemotherapy for first-line treatment of patients diagnosed with advanced stage ovarian, peritoneal or fallopian tube cancer.

II. If both intraperitoneal (IP) regimens significantly improve the PFS event rate compared to the standard regimen, then a second study objective is to determine whether IP cisplatin and intravenous (IV) paclitaxel on day one plus IP paclitaxel on day eight improves the PFS event rate when compared to the IP carboplatin and IV paclitaxel.

SECONDARY OBJECTIVES:

I. To determine if intraperitoneal chemotherapy reduces the overall death rate compared to standard intravenous chemotherapy.

II. To assess the frequency and severity of adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

III. To compare the patient-reported outcomes on: Quality of Life (Function Assessment of Cancer Therapy-Ovarian-Trial Outcome Index [FACT-O-TOI]), Neuropathy (FACT-Gynecologic Oncology Group/Neurotoxicity [GOG/NTX4] scale), Abdominal discomfort (FACT-GOG/AD scale), Fatigue (FACIT-Fatigue scale), and Nausea (item from FACT-O-TOI).

IV. To assess the frequency and the reasons for early discontinuation of the study treatments.

TERTIARY OBJECTIVES:

I. To bank deoxyribonucleic acid (DNA) from whole blood for research and examine the association between
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Progression-free survival [ Time Frame: From date that each patient is enrolled onto the study to the date of the patient's first failure event, assessed up to 10 years ]

Original Primary Outcome: Progression-free survival

Current Secondary Outcome:

  • Frequency and severity of adverse events, as defined by NCI CTCAE version 3.0 [ Time Frame: Up to 10 years ]
    Safety endpoints will be summarized with descriptive statistics for the patients in the safety analysis dataset.
  • Overall survival [ Time Frame: Up to 10 years ]
  • Quality of life and other patient-reported outcomes (e.g., neuropathy, abdominal discomfort, fatigue, and nausea) as assessed by FACT-O-TOI, FACT-GOG/NTX4, FACT-GOG/AD, FACIT-Fatigue, and FACT-Nausea questionnaires [ Time Frame: Up to week 84 ]


Original Secondary Outcome:

  • Overall survival
  • Frequency and severity of adverse events, as defined by NCI CTCAE version 3.0
  • Quality of life and other patient-reported outcomes (e.g., neuropathy, abdominal discomfort, fatigue, and nausea) as assessed by FACT-O-TOI, FACT-GOG/NTX4, FACT-GOG/AD, FACIT-Fatigue, and FACT-Nausea questionnaires


Information By: National Cancer Institute (NCI)

Dates:
Date Received: August 1, 2009
Date Started: July 2009
Date Completion:
Last Updated: December 21, 2016
Last Verified: December 2016