CompletedPhase 2

Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma

United States106 participantsStarted 2001-10

Plain-language summary

This randomized phase II trial is to see if combination chemotherapy works better with or without bevacizumab in treating patients who have malignant mesothelioma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known if combination chemotherapy works better with or without bevacizumab in treating malignant mesothelioma.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically or cytologically confirmed malignant pleural or peritoneal mesothelioma that is not amenable to curative surgery * Epithelial, sarcomatoid, or mixed subtype * Evidence of gross unresectability, including, but not limited to, the following conditions: * Direct extension into the chest wall * Mediastinal or hilar lymphadenopathy * Pulmonary or cardiac function that is inadequate to tolerate resection * Sarcomatoid or mixed histology * Pleural mesothelioma must be stage II or greater using the International Mesothelioma Interest Group staging system * Measurable disease outside prior irradiation port * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Pleural effusions and ascites are not considered measurable lesions * Site in pleura, lung, liver, or retroperitoneum that can be assessed by MRI for evaluation of blood flow * No obvious tumor involvement of major vessels by CT scan * No known brain metastases * Performance status - ECOG 0-1 * More than 3 months * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No history of bleeding diathesis * Bilirubin normal * AST/ALT no greater than 2.5 times upper limit of normal * INR no greater than 1.5 * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * If 1+ or greater proteinuria on dipstick, then must have less than 500 mg of protein/24-hour u…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to disease progression

Timeframe: Time from randomization until the first evidence of progression, up to 9 years

Trial details

NCT IDNCT00027703

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2006-05

View on ClinicalTrials.gov More Advanced Malignant Mesothelioma trials