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

• Status: Active, not recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: Female

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, 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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center; Massachusetts General Hospital
• Collaborators: Genentech, Inc.; National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Antibodies; Antibodies, Monoclonal; Bevacizumab; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. Histologically confirmed epithelial carcinoma of mullerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma will be allowed. All histologic subtypes are eligible.

2. 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.

3. Patient must have undergone surgical staging and debulking with optimal (less than 1cm) cytoreduction.

4. No significant intra-abdominal adhesions or other contraindication to IP port placement.

5. Patients must give written informed consent.

6. Patient must be age 18 years or older.

7. Adequate bone marrow function with an ANC greater that 2,500 and Platelets greater than 100,000 cubic millimeters.

8. 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.

9. ECOG performance status less than or equal to 1.

Exclusion Criteria:

1. 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)

2. ECOG performance status greater than or equal to 2

3. Previous chemotherapy for the disease under study

4. Suboptimal (greater than 1 cm residual disease) cytoreduction

5. Creatinine greater than 1.5 mg/dL

6. SGOT greater than 2 x ULN, bilirubin greater than 1.5 x ULN

7. Colostomy or ileostomy

8. 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.)

9. Known hypersensitivity to E.coli derived products or to any component of Avastin

10. Active psychiatric or mental illness that makes informed consent or careful clinical follow-up unlikely

11. History of myocardial infarction within 6 months

12. History of stroke or transient ischemia attack within 6 months

13. Inadequately controlled hypertension greater than 140/90 mm Hg on antihypertensive medication(s)

14. Any prior history of hypertensive crisis or hypertensive encephalopathy

15. Clinically significant peripheral vascular disease

16. Significant vascular disease (e.g. aortic aneurysm, aortic dissection)

17. Unstable angina

18. New York Heart Association (NYHA) grade II or greater congestive heart failure

19. Evidence of coagulopathy or bleeding diathesis

20. Known central nervous system disease or brain metastases

21. 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

22. 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

23. Open wound, ulcer, or bone fracture

24. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess; current signs and symptoms of bowel obstruction; current dependency on IV hydration or TPN

25. Pregnant (positive pregnancy test) or lactating