Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Patients With Carcinomas of Mullerian Origin

Status unconfirmed · Phase 1

Conditions studied: Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

In brief

The goal of this clinical research study is to learn about the safety and tolerability of paclitaxel and carboplatin when given in combination with Avastin to patients with ovarian, primary peritoneal, or fallopian tube cancer. Objectives: Primary study goals: To investigate the safety and tolerability of carboplatin and paclitaxel administered IP in combination with IV Avastin To determine if Avastin influences the pharmacokinetics of IP administered chemotherapeutic agents Secondary study goals: To determine the systemic exposure to paclitaxel and carboplatin during initial and late cycles of IP dosing. To collect overall survival (OS) and progression-free survival (PFS) To determine changes in IP VEGF levels To determine site of first recurrence Information on CA-125 response and clinical response will be descriptive as secondary goals of this study Exploratory goal: To estimate proportion of patients completing entire course of treatment

Key facts

Study ID

NCT00652119

Run by

Massachusetts General Hospital

People needed

46

Starts

2008-02-01

Expected to finish

2021-08-01

Last updated by the study team

2020-08-19

Who can join

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

You may qualify if…

• Histologically confirmed epithelial carcinoma of mullerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma will be allowed. All histologic subtypes are eligible.
• Stage III or IV disease. Stage IV disease by virtue of pleural effusions is allowed but stage IV disease with visceral metastases e.g. lung, liver or abdominal wall is NOT ELIGIBLE. Please discuss any eligibility concerns directly with the P.I., Dr. Richard Penson.
• Patient must have undergone surgical staging and debulking with optimal (less than 1cm) cytoreduction.
• No significant intra-abdominal adhesions or other contraindication to IP port placement.
• Patients must give written informed consent.
• Patient must be age 18 years or older.
• Adequate bone marrow function with an ANC greater that 2,500 and Platelets greater than 100,000 cubic millimeters.
• No proteinuria or less than +1; if greater, 24-hour urine collection must be performed to document less than or equal to 1gm/24 hours of protein.
• ECOG performance status less than or equal to 1.

You may not qualify if…

• Visible disease on post-operative imaging (recognizing the limitations of postoperative CT scans due to postoperative changes there should be unequivocal CT evidence of residual disease greater than 1cm)
• ECOG performance status greater than or equal to 2
• Previous chemotherapy for the disease under study
• Suboptimal (greater than 1 cm residual disease) cytoreduction
• Creatinine greater than 1.5 mg/dL
• SGOT greater than 2 x ULN, bilirubin greater than 1.5 x ULN
• Colostomy or ileostomy
• Concurrent invasive malignancy. (Patients with concurrent superficial endometrial carcinoma are eligible if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium.)
• Known hypersensitivity to E.coli derived products or to any component of Avastin
• Active psychiatric or mental illness that makes informed consent or careful clinical follow-up unlikely
• History of myocardial infarction within 6 months
• History of stroke or transient ischemia attack within 6 months
• Inadequately controlled hypertension greater than 140/90 mm Hg on antihypertensive medication(s)
• Any prior history of hypertensive crisis or hypertensive encephalopathy
• Clinically significant peripheral vascular disease
• Significant vascular disease (e.g. aortic aneurysm, aortic dissection)
• Unstable angina
• New York Heart Association (NYHA) grade II or greater congestive heart failure
• Evidence of coagulopathy or bleeding diathesis
• Known central nervous system disease or brain metastases
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 28 (first dose of Avastin), anticipation of need for major surgical procedure during the course of the study
• Minor surgical procedures such as fine needle aspirations or core biopsies or laparoscopy for IP catheter placement within 7 days prior to cycle 2 day 8
• Open wound, ulcer, or bone fracture
• History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess; current signs and symptoms of bowel obstruction; current dependency on IV hydration or TPN
• Pregnant (positive pregnancy test) or lactating

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.