A Phase 1 interventional study of adjuvant therapy and paclitaxel in Brenner Tumor, Fallopian Tube Cancer and Ovarian Clear Cell Cystadenocarcinoma, sponsored by National Cancer Institute (NCI). Completed at 19 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-22.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of intraperitoneal carboplatin when administered with paclitaxel during course 1, in patients with stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer who had initial debulking surgery.
II. Determine the feasibility of this regimen in these patients. III. Determine the feasibility of adding IV bevacizumab to this regimen in courses 2-6.
SECONDARY OBJECTIVES:
I. Determine the toxicity profile of this regimen in these patients. II. Determine the toxicity profile of paclitaxel and bevacizumab IV in combination with intraperitoneal carboplatin in these patients.
III. Determine the response rate (in patients with measurable disease who are in the expanded cohort) and progression-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal carboplatin.
Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-40 patients are treated at that dose level.
Patients are followed every 3 months for 1 year.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 113 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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Inclusion Criteria:
Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
The following histologic epithelial cell types are eligible:
Synchronous primary endometrial cancer OR prior history of endometrial cancer allowed provided all of the following are true:
No poorly differentiated subtypes, including the following:
No clinically significant cardiovascular disease, including any of the following:
No prior history of abdominal fistula or gastrointestinal perforation within the past 3-6 months
At least 3 years since prior adjuvant chemotherapy for localized breast cancer
At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin
Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Procedure: adjuvant therapy · Drug: paclitaxel · Drug: carboplatin · Biological: bevacizumab
Given IV
Also known as: Anzatax, Asotax, TAX, Taxol
Given intraperitoneally
Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Given IV
Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Maximum tolerated dose (MTD) of intraperitoneal carboplatin with intravenous paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Time frame: 3 weeks
Incidence of adverse events in patients given intraperitoneal carboplatin with intravenous paclitaxel at the MTD, assessed by CTCAE v3.0
Time frame: 12 weeks
Number of observed DLTs in patients given intraperitoneal carboplatin with intravenous paclitaxel and intravenous bevacizumab, graded using CTCAE v3.0
Time frame: 6 weeks
Incidence of adverse events in patients given intraperitoneal carboplatin with intravenous paclitaxel and intravenous bevacizumab, graded using CTCAE v3.0
Time frame: 12 weeks
Response rate (in patients with measurable disease who are in the expanded cohort) assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to 1 year
Progression-free survival assessed by RECIST
Time frame: From study entry until disease progression, death or date of last contact, up to 1 year
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)