Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites
| Status: | Terminated |
|---|---|
| Conditions: | Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2015 |
| End Date: | August 2015 |
This study will evaluate the safety and efficacy of intraperitoneal administration of
Bevacizumab to prevent the recurrence of malignant ascites. Ten patients will receive
intraperitoneal Bevacizumab 200 mg in 250 ml of normal saline for infusion every two weeks
for up to six weeks, or a maximum of three treatments.
Bevacizumab to prevent the recurrence of malignant ascites. Ten patients will receive
intraperitoneal Bevacizumab 200 mg in 250 ml of normal saline for infusion every two weeks
for up to six weeks, or a maximum of three treatments.
This protocol describes a pilot study to assess whether intraperitoneal Bevacizumab infusion
is safe and improves the time to repeat paracentesis. In patients with non-draining
malignant peritoneal effusion, published data suggests that the average time to repeat
paracentesis in malignant ascites is 10-13 Days. The investigators' treatment will be
considered potentially efficacious if the median time to repeat paracentesis is greater than
14 days.
is safe and improves the time to repeat paracentesis. In patients with non-draining
malignant peritoneal effusion, published data suggests that the average time to repeat
paracentesis in malignant ascites is 10-13 Days. The investigators' treatment will be
considered potentially efficacious if the median time to repeat paracentesis is greater than
14 days.
Inclusion Criteria:
- Patients will be included in the case of:
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
- Participants must be 18 years of age or older
- Have ascites of malignant disease
- Have symptoms related to ascites
- Ascites Index above 0.05 (AI ˃ 0.05)
- Be an English speaking patient or have an interpreter available
- Be able to understand and comply with all study requirements and the
implications of off-label use of intraperitoneal Bevacizumab
- Have had at least two paracentesis within the last 4 weeks
Exclusion Criteria:
- Patients will be excluded in the case of:
- Ascites due to non-malignant cause
- Concurrent treatment with systemic chemotherapy that has a realistic chance of
controlling the ascites
- Concurrent treatment with intraperitoneal Bevacizumab
- life expectancy of less than 2 weeks
- A history of bowel perforation or fistula
- Symptoms or signs suggestive of bacterial peritonitis
- Child's C cirrhosis
- Uncontrolled hypertension
- Surgery within 28 days of catheter treatment
- Evidence of coagulopathy
- Symptoms suggestive of bowel obstruction
- Major surgery, open biopsy or significant traumatic injury within seven (7) days
of first study drug--including neurosurgery.
- Inability to complete informed consent process and adhere to the protocol
treatment plan and follow-up requirements.
- Concurrent severe illness such as active infection, or psychiatric
illness/social situations that would limit safety and compliance with study
requirements
- Patients who are pregnant or lactating (females of childbearing potential must
have a negative pregnancy test prior to participation)
- Patients with pre-existing 3 + or greater urine dipstick reading proteinuria
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