Malignant AscitesPhase 1NCT02496286
Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites
A Phase 1 study testing Intraperitoneal Bevacizumab in people with Malignant Ascites, run by Eastern Regional Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Ascites
- What is being tested?
- Intraperitoneal Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Aug 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
About this study
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.
Read the detailed description
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.
- Conditions
- Malignant Ascites
- Being tested
- Intraperitoneal Bevacizumab
- Keywords
- Necessary paracentesis for symptom control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal BevacizumabDrug
Bevacizumab 200mg diluted in 250 ml of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients requiring paracentesis for symptom control | Experimental | Not described Receives: Drug: Intraperitoneal Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Improvement
Radiographic improvement in area of intraperitoneal collection will be evaluated (between the area of the intraperitoneal collection on the ultrasound pre-procedure and ultrasound evaluation on day 14 (+/-4 days).
Measured: 14 days (+/-4 days)
Volume Output
Change in volume output from baseline to day 14 (+/-4 days)
Measured: 14 days (+/-4 days)
Secondary outcomes (1)
Adverse Events
Adverse events will be judged possibly or probably related to intraperitoneal Bevacizumab infusion.
Measured: 14 days (+/-4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Lack of Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496286
- Sponsor's protocol ID
- EP2014013
- Status last verified
- Jul 2017
- First submitted
- 1 Jul 2015
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites
- ClinicalTrials.gov ID
- NCT02496286
- Acronym / sponsor ID
- EP2014013
- Conditions
- Malignant Ascites
- Keywords
- Necessary paracentesis for symptom control
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Enrollment
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Eastern Regional Medical CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients requiring paracentesis for symptom control | Experimental | Drug: Intraperitoneal Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients will be included in the case of:
Key exclusion criteria (17 listed)
- Patients will be excluded in the case of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraperitoneal BevacizumabBevacizumab 200mg diluted in 250 ml of normal saline | Drug | Eligible patients requiring paracentesis for symptom control |
Primary outcome
Radiographic Improvement
Time frame: 14 days (+/-4 days)
Radiographic improvement in area of intraperitoneal collection will be evaluated (between the area of the intraperitoneal collection on the ultrasound pre-procedure and ultrasound evaluation on day 14 (+/-4 days).
Volume Output
Time frame: 14 days (+/-4 days)
Change in volume output from baseline to day 14 (+/-4 days)
1 secondary outcome
Adverse Events
Time frame: 14 days (+/-4 days)
Results and safety
The study was stopped early (reason given: Lack of Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intraperitoneal Bevacizumab in people with Malignant Ascites, run by Eastern Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of Enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Improvement (time frame: 14 days (+/-4 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.