Bevacizumab for Peritoneal Malignant Mesothelioma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Abbott-Northwestern Hospital, Minneapolis, MN
Peritoneal Malignant Mesothelioma+2 More
Bevacizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether immunotherapy (atezolizumab) plus the usual treatment is better than the usual treatment alone in treating patients with peritoneal mesothelioma.

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Eligible Conditions

  • Peritoneal Malignant Mesothelioma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Bevacizumab will improve 1 primary outcome, 6 secondary outcomes, and 1 other outcome in patients with Peritoneal Malignant Mesothelioma. Measurement will happen over the course of From study entry to death from any cause, assessed up to 3 years.

Year 3
Overall survival
Year 3
Progression-free survival (PFS)
Up to 3 years
Completeness of cytoreduction
Conversion rate to surgical resection among those not deemed to be surgical candidates
Incidence of adverse events
Major pathologic response rate
Soluble mesothelin-related peptides and megakaryocyte potentiating factor
Year 4
Response rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm II (carboplatin, pemetrexed, bevacizumab)
1 of 2
Arm I (carboplatin, pemetrexed, bevacizumab, atezolizumab)
1 of 2
Active Control
Experimental Treatment

This trial requires 66 total participants across 2 different treatment groups

This trial involves 2 different treatments. Bevacizumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm I (carboplatin, pemetrexed, bevacizumab, atezolizumab)Patients receive atezolizumab IV over 60 minutes, bevacizumab IV over 30-90 minutes, carboplatin IV over 30 minutes, and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks, patients undergo cytoreductive surgery and HIPEC. Patients not eligible for surgery may receive atezolizumab and bevacizumab in the absence of disease progression or unacceptable toxicity.
Arm II (carboplatin, pemetrexed, bevacizumab)Patients receive bevacizumab IV over 30-90 minutes, carboplatin IV over 30 minutes, and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks, patients undergo cytoreductive surgery and HIPEC. Patients not eligible for surgery may receive bevacizumab with or without atezolizumab at the discretion of the investigator in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Bevacizumab
FDA approved
Carboplatin
FDA approved
Cytoreductive Surgery
2011
Completed Phase 1
~150
Hyperthermic Intraperitoneal Chemotherapy
2010
Completed Phase 3
~190
Pemetrexed
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from study entry to the first of either disease progression or death from any cause, where disease progression will be determined based on response evaluation criteria in solid tumors (recist) 1.1 criteria, assessed up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from study entry to the first of either disease progression or death from any cause, where disease progression will be determined based on response evaluation criteria in solid tumors (recist) 1.1 criteria, assessed up to 3 years for reporting.

Closest Location

Abbott-Northwestern Hospital - Minneapolis, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically or cytologically confirmed malignant peritoneal mesothelioma for which there has been no prior treatment. Given the indolent nature of well-differentiated papillary mesothelioma and multicystic mesothelioma, patients with these variants are not eligible for participation
All slides including performed immunostains from diagnostic tumor tissue together with pathology report for retrospective central pathology review
Must have measurable disease per RECIST version (v) 1.1
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 28 days prior to registration is required
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Leukocytes >= 2,500/mm^3
Absolute neutrophil count (ANC) >= 1,500/mm^3
Platelet count >= 100,000/mm^3
Creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

Patient Q&A Section

What are common treatments for mesothelioma?

"There has been a significant improvement in average survival time and quality of life since the 1980s. Although many patients remain symptomatic for years after diagnosis, their symptoms often improve over time. Recent findings showed that surgery was not always necessary. Surgery should be considered only for those who are candidates for extrapleural pneumonectomy (EPP). For patients who are not surgical candidates, chemotherapy should be used as part of multimodality treatment. Patients with unresectable disease should receive palliative care." - Anonymous Online Contributor

Unverified Answer

Is bevacizumab safe for people?

"Bevacizumab is well tolerated in patients with metastatic malignancy. It does not seem to have a significant impact on serious adverse events or clinical outcomes. This trial was registered at www.anzctr.org.au/trial_view.aspx?ID=3000057." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving bevacizumab?

"Clinical trials of bevacizumab have demonstrated that the drug has no effect on overall survival; however, more patients had metastatic disease when bevacizumab was given compared to placebo. When metastatic disease worsens, the patient's prognosis improves significantly. Data from a recent study shows that bevacizumab does not appear to increase overall survival in patients with recurrent or metastatic pancreatic cancer." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets mesothelioma?

"When comparing ages across countries, we found that mean age of diagnosis was lowest in New Zealand at 56.5 yr and highest in Canada at 70 yr. Countries with a lower proportion of women, such as Belgium, France, Germany, Italy, Sweden, and Switzerland had an earlier mean age at diagnosis of 59 yr, whereas countries with a higher proportion of women, such as Australia, Spain, and the United Kingdom, had a later mean age at diagnosis of 63 yr." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for mesothelioma?

"Clinical trials seem to offer little benefit to patients with recurrent disease after chemotherapy. However, they may improve survival in patients with localized disease, particularly those who have not received surgery as part of their initial treatment. Clinical trials for mesothelioma should focus on evaluating more effective systemic therapies." - Anonymous Online Contributor

Unverified Answer

Does bevacizumab improve quality of life for those with mesothelioma?

"The overall findings suggest that this drug may improve QOL in those with recurrent/metastatic MEC. However, individual differences in baseline QOL may influence the impact of bevacizumab on QOL. Further research is required to confirm these findings and to investigate whether the magnitude of change in QOL, abnormalities detected during therapy, and the duration of bevacizumab therapy are associated with improved survival." - Anonymous Online Contributor

Unverified Answer

What causes mesothelioma?

"Alcoholic beverage consumption is associated with an increased risk of developing mesothelioma. Smoking may increase the risk of developing mesothelioma. Asbestos is a common environmental carcinogen that is associated with mesothelioma. Specific types of asbestos are particularly hazardous." - Anonymous Online Contributor

Unverified Answer

What is mesothelioma?

"Mesothelioma is caused by asbestos exposure. There are many types of mesothelioma. The most common type is called sarcomatous mesothelioma. This form typically develops after asbestos exposure. Other forms of mesothelioma occur less often and include biphasic, desmoplastic, epithelioid, and clear cell and giant cell subtypes. These last three types appear more commonly in women. Desmoplastic and biphasic mesotheliomas are usually benign. Sarcomatous mesothelioma can progress to metastatic disease (cancer spreading to distant sites), even when the primary tumor has had a long period of dormancy as a result of treatment." - Anonymous Online Contributor

Unverified Answer

What are the signs of mesothelioma?

"Mesothelioma has several symptoms, which include a cough, shortness of breath, chest pain, weight loss, fever, fatigue, and night sweats.\n\nMesothelioma is also associated with other cancers of the respiratory tract, such as lung squamous cell carcinoma, small cell lung cancer, adenocarcinoma, adenosquamous carcinoma, and sarcomatoid carcinoma. Most metastatic cancers form in the brain, liver, or lymph nodes. Symptoms depend on where in the body the cancer is located.\n\nThe typical mesothelioma tumor usually appears as a mass on medical imaging techniques." - Anonymous Online Contributor

Unverified Answer

How does bevacizumab work?

"In a recent study, no significant difference was seen in PFS between bevacizumab and placebo-treated patients in patients with malignant mesothelioma. This suggests that bevacizumab may prolong survival only in a subgroup of patients with recurrent disease who either do not have systemic metastasis or have distant metastases during adjuvant therapy." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for mesothelioma?

"Survival rates for patients who develop metastatic disease are low, even for those whose primary disease has been successfully controlled. The behavior of mesothelioma cells is complex and multifactorial, and depends upon the type of cell involved, the location of origin within the body, and the stage of dissemination. Overall, survival rates for patients with localised disease have improved over time, although this may partly be due to earlier recognition and treatment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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