Status:
UNKNOWN
Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Patients With Carcinomas of Mullerian Origin
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Genentech, Inc.
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Peritoneal Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
The Study Drugs: Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die. Paclitaxel is designed to block the mechanisms of c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00652119
Start Date
February 1 2008
End Date
August 1 2021
Last Update
August 19 2020
Active Locations (5)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
4
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030