Paclitaxel, Bevacizumab And Adjuvant Intraperitoneal Carboplatin in Treating Patients Who Had Initial Debulking Surgery for Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Completed · Phase 1

Conditions studied: Brenner Tumor, Fallopian Tube Cancer, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mixed Epithelial Carcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Undifferentiated Adenocarcinoma, Primary Peritoneal Cavity Cancer, Stage II Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

In brief

This phase I trial is studying the side effects and best dose of adjuvant intraperitoneal carboplatin when given together with paclitaxel and bevacizumab in treating patients who have undergone debulking surgery for stage II , stage III, or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin and paclitaxel in treating ovarian epithelial or primary peritoneal cancer, or fallopian tube cancer.

Key facts

Study ID

NCT00079430

Run by

National Cancer Institute (NCI)

People needed

113

Starts

2004-06-01

Last updated by the study team

2019-07-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
• Stage II-IV disease
• The following histologic epithelial cell types are eligible:
• Serous adenocarcinoma
• Mucinous adenocarcinoma
• Clear cell adenocarcinoma
• Transitional cell carcinoma
• Adenocarcinoma not otherwise specified
• Endometrioid adenocarcinoma
• Undifferentiated carcinoma
• Mixed epithelial carcinoma
• Malignant Brenner's tumor
• Optimal (≤ 1 cm residual disease) OR suboptimal residual disease after initial debulking surgery (performed within the past 12 weeks)
• Synchronous primary endometrial cancer OR prior history of endometrial cancer allowed provided all of the following are true:
• Stage IB disease or less
• Less than 3 mm invasion without vascular or lymphatic invasion
• No poorly differentiated subtypes, including the following:
• Papillary serous
• Clear cell
• Other FIGO grade 3 lesions
• No epithelial tumors of low malignant potential (borderline tumors)
• No CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or brain metastases by history or evidence upon physical examination within the past 6 months
• Performance status - GOG 0-2
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3

Where it is running

• University of California Medical Center At Irvine-Orange Campus — Orange, California, United States
• University of Chicago — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
• Cooper Hospital University Medical Center — Camden, New Jersey, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• Cancer Care Associates-Midtown — Tulsa, Oklahoma, United States
• Tulsa Cancer Institute — Tulsa, Oklahoma, United States
• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Women and Infants Hospital — Providence, Rhode Island, United States
• M D Anderson Cancer Center — Houston, Texas, United States
• Pacific Gynecology Specialists — Seattle, Washington, United States
• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Kawasaki Medical School — Okayama-Ken, Kurashiki, Japan
• Saitama Medical University International Medical Center — Saitama, Japan

Full record on ClinicalTrials.gov

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