Carboplatin and Paclitaxel With or Without Bevacizumab Compared to Docetaxel, Carboplatin, and Paclitaxel in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Carcinoma (Cancer)
Completed · Phase 1
Conditions studied: Brenner Tumor, Fallopian Tube Cancer, Ovarian Carcinosarcoma, 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 intraperitoneal infusions of carboplatin when given together with intravenous infusions of either docetaxel or paclitaxel followed by intraperitoneal paclitaxel in treating patients with stage II, stage III, or stage IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma (cancer). Drugs used in chemotherapy, such as carboplatin, docetaxel, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells
Key facts
- Study ID
- NCT00085358
- Run by
- National Cancer Institute (NCI)
- People needed
- 40
- Starts
- 2004-05-01
- 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 fallopian tube, ovarian epithelial, or primary peritoneal carcinoma
- Stage II-IV disease
- The following epithelial cell types are allowed:
- Carcinosarcoma
- Serous adenocarcinoma
- Endometrioid adenocarcinoma
- Mucinous adenocarcinoma
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Mixed epithelial carcinoma
- Transitional cell carcinoma
- Malignant Brenner's tumor
- Adenocarcinoma not otherwise specified
- Must have undergone prior surgery for ovarian or peritoneal carcinoma within the past 12 weeks
- Optimal (≤ 1 cm residual disease) or suboptimal residual disease following initial surgery
- Must have a procedure for determining diagnosis of ovarian/peritoneal carcinoma with appropriate tissue for histologic evaluation
- Synchronous primary endometrial cancer or prior endometrial cancer allowed provided the following criteria are met:
- Stage ≤ IB
- Less than 3 mm invasion without vascular or lymphatic invasion
- No poorly differentiated subtypes (e.g., grade 3, clear cell, or papillary serous)
- No epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)
- No CNS disease (e.g., seizures not controlled with standard medical therapy) or metastasis
- GOG performance status 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
- Colorado Gynecologic Oncology Group — Aurora, Colorado, United States
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- Greater Baltimore Medical Center — Baltimore, Maryland, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Cooper Hospital University Medical Center — Camden, New Jersey, United States
- Case Western Reserve University — Cleveland, Ohio, United States
- Cleveland Clinic Cancer Center/Fairview Hospital — Cleveland, Ohio, United States
- Lake University Ireland Cancer Center — Mentor, Ohio, United States
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
- Cancer Care Associates-Midtown — Tulsa, Oklahoma, United States
- Cancer Care Associates-Yale — Tulsa, Oklahoma, United States
- Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States
- Women and Infants Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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