Refractory Malignant AscitesPhase 1NCT01852409
Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites
A Phase 1 study testing bevacizumab in people with Refractory Malignant Ascites, run by Peking University at 2 sites in China.
Trial summary
Malignant ascites often has a profound impact on the quality of life of cancer patients. Current treatments,including dietary, medical, and procedural are often temporary and unsatisfactory options in patients approaching the end of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory Malignant Ascites
- What is being tested?
- bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesChina
- Study dates
- May 2013to Jun 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form;
- Histologically or cytologically confirmed non-squamous cell carcinoma，including colorectal cancer, gastric cancer, esophageal cancer, pancreatic cancer, bile duct cancer, ovarian cancer, peritoneal primary tumor;Ascites were diagnosed by ultrasound or CT and confirmed malignant ascites by cytology;
- failed to standard systemic therapy and / or no appropriate treatment for the treatment for malignant ascites
- Age 18-70 years;
- Performance Status- Eastern Cooperative Oncology Group (ECOG)≤2;
- Life expectancy of at least 8 weeks;
Who cannot join
- systematic anti-cancer therapy, including chemotherapy (intraperitoneal chemotherapy), radiation therapy, immunotherapy, biological or hormone therapy performed within 2 weeks;
- tyrosine kinase inhibitors or monoclonal antibodies of anti-vascular endothelial growth factor (VEGF) performed within 4 weeks;
- Laboratory tests:Absolute neutrophil count<1.0x109/L,Platelet count<75x 109/L,Hemoglobin<8g/dl,PT-INR≥1.5 times upper limit of normal (ULN);Bilirubin≥2 x ULN,AST and ALT≥2.5 times ULN(no liver metastasis),≥5 times ULN(with liver metastasis)Creatinine≥1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula,<40 mL/min;
- uncontrolled hypertension:systolic pressure ≥160 mmHg,or diastolic pressure≥100mmHg
- Known history of severe heart disease,uncontrolled or symptomatic angina, congestive heart failure,clinically significant arrhythmias,myocardial infarction within six months;
- active (severe or uncontrolled) bleeding (hemorrhage within 3 months> 30 ml), hemoptysis (fresh blood, 4 weeks> 5 ml), bloody ascites
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- thrombosis, tumor thrombus events (including arterial/venous thrombosis, tumor thrombosis, pulmonary embolism, transient ischemic attack)within 12 months;
- Portal hypertensive disease or severe liver disease, including various types of cirrhosis, obstructive jaundice;
- concurrent gastrointestinal obstruction, peptic ulcer, Crohn's disease, ulcerative colitis and other gastrointestinal diseases according to investigators' determination that may cause gastrointestinal bleeding or perforation;
- concurrent severe respiratory disease, or chronic therapy with oxygen or corticosteroids, such as chronic obstructive pulmonary disease, interstitial lung disease, etc.
- Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2 or not recovered from surgery;
- Symptomatic brain metastasis;
- Uncontrolled systemic disease,such as infection,unstable diabetes mellitus,etc;
- Active infection of HIV、HBV、HCV；
- Major surgery within 4 weeks of start of study treatment, without complete recovery.
- Pregnant or lactating women.Negative serum pregnancy test (For women of childbearing potential);Fertile patients must use effective contraception.
- Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
- Received any investigational drug treatment within 4 weeks of start of study treatment.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 1 recruiting
- Active, not recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, M.D., 861088196561, lin100@medmail.com.cn
Jifang Gong, M.D., 861088196561, gongjifang@gmail.com
About this study
Official title: Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites.
Malignant ascites often has a profound impact on the quality of life of cancer patients. Current treatments,including dietary, medical, and procedural are often temporary and unsatisfactory options in patients approaching the end of life. Intraperitoneal bevacizumab for the palliation of malignant ascites might be a novel choice for refractory malignant ascites.
- Conditions
- Refractory Malignant Ascites
- Being tested
- bevacizumab
- Keywords
- refractory malignant ascites, Bevacizumab, intraperitoneal, phase I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
Also called Avastin
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab | Experimental | The study evaluate 4 dose level of bevacizumab:2.5mg /kg;5 mg /kg;7.5mg /kg; 1.25mg /kg; Receives: Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
participants will be followed for the duration of hospital stay, an expected average of 1 week
Measured: during the treatment in the hospital,an expected average of 1 week
Maximum tolerated dose
during the treatment in the hosptital
Measured: 1 week
Secondary outcomes (3)
Objective response rate
ultrasound will be performed every week for efficacy evaluation
Measured: 1 week
time to treatment failure(TTF)
the follow-up visit of time to TTF will be performed every 4 weeks
Measured: 1 month
time to death(TTD)
TTD means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 2 months till death or lost
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractory Malignant AscitesStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852409
- Sponsor's protocol ID
- CGOG6001
- Status last verified
- May 2013
- First submitted
- 8 May 2013
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kou F, Gong J, Li Y, Li J, Zhang X, Li J, Shen L. Phase I study of intraperitoneal bevacizumab for treating refractory malignant ascites. J Int Med Res. 2021 Feb;49(2):300060520986664. doi: 10.1177/0300060520986664.
PubMed 33616416
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites.
- ClinicalTrials.gov ID
- NCT01852409
- Acronym / sponsor ID
- CGOG6001
- Conditions
- Refractory Malignant Ascites
- Keywords
- refractory malignant ascites, Bevacizumab, intraperitoneal, phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 13 May 2013 (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.
Malignant ascites often has a profound impact on the quality of life of cancer patients. Current treatments,including dietary, medical, and procedural are often temporary and unsatisfactory options in patients approaching the end of life. Intraperitoneal bevacizumab for the palliation of malignant ascites might be a novel choice for refractory malignant ascites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bevacizumab | Experimental | Drug: bevacizumabThe study evaluate 4 dose level of bevacizumab:2.5mg /kg;5 mg /kg;7.5mg /kg; 1.25mg /kg; |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent form;
- Histologically or cytologically confirmed non-squamous cell carcinoma，including colorectal cancer, gastric cancer, esophageal cancer, pancreatic cancer, bile duct cancer, ovarian cancer, peritoneal primary tumor;Ascites were diagnosed by ultrasound or CT and confirmed malignant ascites by cytology;
- failed to standard systemic therapy and / or no appropriate treatment for the treatment for malignant ascites
- Age 18-70 years;
- Performance Status- Eastern Cooperative Oncology Group (ECOG)≤2;
Key exclusion criteria (18 listed)
- systematic anti-cancer therapy, including chemotherapy (intraperitoneal chemotherapy), radiation therapy, immunotherapy, biological or hormone therapy performed within 2 weeks;
- tyrosine kinase inhibitors or monoclonal antibodies of anti-vascular endothelial growth factor (VEGF) performed within 4 weeks;
- Laboratory tests:Absolute neutrophil count<1.0x109/L,Platelet count<75x 109/L,Hemoglobin<8g/dl,PT-INR≥1.5 times upper limit of normal (ULN);Bilirubin≥2 x ULN,AST and ALT≥2.5 times ULN(no liver metastasis),≥5 times ULN(with liver metastasis)Creatinine≥1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula,<40 mL/min;
- uncontrolled hypertension:systolic pressure ≥160 mmHg,or diastolic pressure≥100mmHg
- Known history of severe heart disease,uncontrolled or symptomatic angina, congestive heart failure,clinically significant arrhythmias,myocardial infarction within six months;
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 |
|---|---|---|
| bevacizumabAlso: Avastin | Drug | bevacizumab |
Primary outcome
adverse events
Time frame: during the treatment in the hospital,an expected average of 1 week
participants will be followed for the duration of hospital stay, an expected average of 1 week
Maximum tolerated dose
Time frame: 1 week
during the treatment in the hosptital
3 secondary outcomes
Objective response rate
Time frame: 1 week
time to treatment failure(TTF)
Time frame: 1 month
time to death(TTD)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
- Derived from this study: PubMed 33616416Kou F, Gong J, Li Y, Li J, Zhang X, Li J, Shen L. Phase I study of intraperitoneal bevacizumab for treating refractory malignant ascites. J Int Med Res. 2021 Feb;49(2):300060520986664. doi: 10.1177/0300060520986664.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bevacizumab in people with Refractory Malignant Ascites, run by Peking University at 2 sites in China.
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 6 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Shen, M.D. (861088196561, lin100@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: during the treatment in the hospital,an expected average of 1 week). 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?
On the ClinicalTrials.gov record for NCT01852409, which also lists 1 linked publication.
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 21 May 2013.