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Mesothelioma Antiangiogenesis Clinical Trials
Search Criteria
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Summary Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone. Further Study Information A phase II trial associating the reference chemotherapy (pemetrexed plus cisplatin) with bevacizumab is needed to ensure that no specific toxicity is induced by this association, and that this triplet have interesting activity. As pleural mesothélioma is a rare tumor, a phase III trial, using the survival data from the phase II part study, will be able to include a sufficient number of patients, in a reasonable period of time, to answer the question of efficacy of the anti-angiogenic triplet, providing the efficacy outcomes could be considered as favorable, at the end of the phase II part of the study. Eligibility Criteria Inclusion Criteria:
Exclusion Criteria:
Trial Lead Organizations/Sponsors French Thoracic Oncology Intergroup Center CHU de Caen Groupe Francais de Pneumo-Cancerologie European Lung Cancer Working Party
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Summary This will be a single institution non-randomized phase I/II trial for patients with malignant mesothelioma stage II and above, who have not received prior chemotherapy for their disease. The purpose of this phase is to select a dose of VEGF-AS (antiangiogenesis drug)to be given with standard doses of pemetrexed followed by cisplatin on day 1 of a 21-day cycle. Further Study Information The Study Objectives in Phase I are: To determine the safety of the combination of VEGF-Antisense Oligonucleotide (VEGF-AS, Veglin™) plus Pemetrexed and Cisplatin in subjects with advanced Malignant Mesothelioma,.via a dose escalation protocol. To determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of VEGF-AS plus Premetrexed and Cisplatin. To determine the time to disease progression To determine the objective response rate of the combination of VEGF-AS plus Pemetrexed and Cisplatin for the treatment of advanced malignant mesothelioma The study Objectives in Phase II are: To further characterize the toxicity experienced by patients with malignant mesothelioma treated with VEGF-AS plus Cisplatin and Pemetrexed. To determine median and overall survival. The Laboratory objectives are: To measure plasma VEGF levels before, during, and after therapy as a correlate of outcome. To determine the pharmacokinetic profile of VEGF-AS plus Pemetrexed and Cisplatin. Eligibility Criteria Inclusion Criteria:
Absolute neutrophil count greater than or equal to1,500 Platelets greater than or equal to 100,000 Total bilirubin less than or equal to2.0x the upper limits of institutional normal AST/ALT less than or equal to 2.0x the upper limits of institutional normal Creatinine Clearance greater than 50ml/min
Exclusion Criteria:
Trial Lead Organizations/Sponsors USC/Norris Comprehensive Cancer Center and Hospital Sponsor Name Pending
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AZD2171 in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery Objectives Primary
Secondary
Tertiary
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
Patient Characteristics:
Trial Lead Organizations University of Chicago Cancer Research Center
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Summary To estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab Further Study Information Secondary endpoints will include: objective response rate overall survival In addition, the objective of the analysis of the correlative science data is to determine any association between tumor expression of VEGF/KDR complex and/or the presence of sv40 (as detected by PCR amplification) and objective response. Eligibility Criteria Inclusion criteria 5.2.1 Patients must have histologically proven malignant mesothelioma (epithelial, sarcomatoid, or mixed subtype) not amenable to curative surgery or radiotherapy. Eligible sites of origin include the pleura, peritoneum, and tunica vaginalis. 5.2.2 Patient's disease must not be amenable to curative treatment with surgery. Evidence of gross unresectability will include but not be limited to direct extension into the chest wall, mediastinal or hilar lymphadenopathy, pulmonary or cardiac function that is inadequate to tolerate resection, and sarcomatoid or mixed histology. 5.2.3 Patients must be > 18 years old 5.2.4 Patients must have measurable disease. Adequate organ function and functional status Exclusion Criteria: a. General Medical Concerns 5.3.1 Patients must not be pregnant or breast feeding. 5.3.2 No "currently active" second malignancy other than non-melanoma skin cancer. Patients are not considered to have a "currently active" second malignancy if they have completed therapy and have a less than 30% risk of relapse. 5.3.3 No uncontrolled intercurrent illness including but not limited to: active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social situations that would limit compliance with study requirements. 5.3.4 No HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with study medications. 5.3.5 History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in the study. 5.3.6 Inability to interrupt aspirin or other non-steroidal medication for a 5 day period. c. Bevacizumab-Specific Concerns Subjects meeting any of the following criteria are ineligible for study entry: 5.3.7 Patients with brain metastases are excluded 5.3.8 History of myocardial infarction or CVA (stroke) within 6 months of study entry. 5.3.9 Evidence of bleeding diathesis or coagulopathy. Patients on therapeutic doses of coumadin are eligible as long as the INR is maintained in the range of 2-3 and there is no evidence of active bleeding. 5.3.10 Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study 5.3.11 Urine protein:creatinine ratio less than 1.0 at screening 5.3.12 Serious, non-healing wound, ulcer, or bone fracture Trial Lead Organizations/Sponsors Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas University of Chicago Cancer Research Center Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
Patient Characteristics:
Trial Lead Organizations NCIC-Clinical Trials Group
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Summary The primary objective is to assess antitumor activity of the combination of bevacizumab, pemetrexed and carboplatin, in terms of time to progression. Further Study Information Secondary endpoints are to evaluate:
Eligibility Criteria Inclusion Criteria:
Exclusion Criteria:
Trial Lead Organizations/Sponsors Istituto Clinico Humanitas
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Bortezomib and Cisplatin as First-Line Therapy in Treating Patients With Malignant Mesothelioma Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
Patient Characteristics:
Trial Lead Organizations European Organization for Research and Treatment of Cancer
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Pazopanib in Treating Patients With Malignant Pleural Mesothelioma Objectives Primary
Secondary
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
[Note: *Insertion of a vascular access device is not considered major or minor surgery] Patient Characteristics:
Trial Lead Organizations North Central Cancer Treatment Group
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Summary The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic malignant pleural mesothelioma patients treated with NGR-hTNF as single agent. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria. Further Study Information This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen , that will be conducted using Simon's two-stage design method. Eligibility Criteria Inclusion Criteria:
Exclusion Criteria:
Trial Lead Organizations/Sponsors MolMed S.p.A.
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Summary This study is using the combination of radiation and antiangiogenic agents (agents that destroy existing blood vessels) seems to be an approach to tumor cure. Further Study Information The combination of ionizing radiation and antiangiogenic agents seems to be a counterintuitive approach to tumor cure because oxygen is a potent radiosensitizer and a reduction in oxygen concentration would be expected following a reduction in tumor vasculature after antiangiogenic treatment. Eligibility Criteria Inclusion Criteria:
Exclusion Criteria:
Trial Lead Organizations/Sponsors Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Summary Primary Objectives: 1. To establish acceptable dosages of paclitaxel, oxaliplatin and bevacizumab in a regimen of intravenous bevacizumab followed by continuous intravenous infusion of paclitaxel on day 1, intraperitoneal oxaliplatin on day 2, and intraperitoneal paclitaxel on day 8 once every 3 weeks in patients with advanced peritoneal carcinomatosis. 2. To assess toxicity profile. 3. To assess clinical responses. Further Study Information THE STUDY DRUGS: Paclitaxel is designed to block cancer cells from dividing, which may cause them to die. Oxaliplatin is designed to keep new cancer cells from growing Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels. SCREENING TESTS: Before you can receive the study drugs on this study, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests will be performed:
STUDY DRUG DOSE LEVELS: Up to 12 study drug dose levels will be tested in this study. Participants will be enrolled in groups of 3. The first 3 participants will be enrolled at the lowest dose level. If there are no intolerable side effect seen, the next 3 participants will be enrolled into the next higher dose level. This will continue until acceptable dose levels of the study drugs are found. The dose level that you are assigned to will depend on when you enroll on this study. You will receive the same dose level for the entire study unless you develop side effects, in which case doses of the drugs will be decreased by your doctor. DRUG ADMINISTRATION: If you agree to participate in this study, you will have a catheter placed in your abdomen before receiving study drug. A catheter is a sterile flexible tube that will be placed while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form. On Day 1, you will receive bevacizumab followed by paclitaxel through a needle in your vein over 24 hours. On Day 2, after you have completed the paclitaxel infusion, you will be given about 1 quart of fluid containing oxaliplatin into the abdomen through the catheter over 15 minutes. On Day 8, you will be given about 1 quart of fluid containing paclitaxel into the abdomen through the catheter over 15 minutes. Every 21 days is called a study "cycle." STUDY VISITS: During each cycle, you will see your doctor in his office to make sure that you are still eligible to receive study drugs.
LENGTH OF STUDY: You may receive up to 6 cycles of study drugs. You will be taken off study if the disease gets worse or intolerable side effects occur. END-OF-STUDY VISIT: If you are taken off study, you will be asked to have an end-of-study visit. At this visit, the following tests will be performed:
This is an investigational study. Paclitaxel, oxaliplatin, and bevacizumab are FDA-approved drugs, but their use in this study is investigational. The costs of these drugs (paclitaxel, oxaliplatin and bevacizumab) will be the responsibility of you and/or your insurance provider. You should be aware that bevacizumab might not be paid for by your insurance company and is expensive. Up to 72 patients will take part in this study. All will be enrolled at M. D. Anderson. Eligibility Criteria Inclusion Criteria: 1. Patients must have advanced peritoneal carcinomatosis: they have either a disease where there is no established standard of care therapy or have failed one or more prior therapy. These include, but not limited to, recurrent epithelial ovarian cancer, advanced endometrial cancer, advanced gastric cancer, advanced colorectal cancer, and advanced primary peritoneal mesothelioma without significant chest involvement. Previous intraperitoneal therapy with different agents is allowed as long as their diseases have progressed. 2. Patients must have ECOG performance status < or = 2 (0-2). 3. Patients must have normal organ and marrow function as defined below: Absolute neutrophil count > or = 1,500/mcL Platelets > or = 100,000/mcL Total bilirubin < or = 2.0 and ALT <2.5 X the institutional upper limit of normal; Creatinine < or = 2.0 mg/dL or creatinine clearance > or = 40mL/min/1.73m2. 4. Patients must be able to understand and the willingness to sign an IRB-approved written informed consent document. 5. Patients must have evidence of peritoneal carcinomatosis that is evaluable by CT or MRI. 6. In the clinical judgment of the investigator, patients must have adequate potential intraperitoneal fluid distribution with no gross fluid loculations and adhesions that would significantly affect intraperitoneal drug distribution. This determination may be made based on documented clinical, imaging or laboratory assessment. 7. Patients must have PT/PTT within 1.2 x the institutional upper limit of normal or < 3 x the institutional upper limit of normal on anticoagulants. 8. Patients must have resting blood pressure no greater than 140 mmHg(systolic) or 90 mmHg (diastolic) for eligibility. Initiation or adjustment of blood pressure medication is permitted prior to study entry. Exclusion Criteria: 1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, symptomatic cardiac arrhythmia, active bleeding, active thrombosis, or psychiatric illness/social situations that would limit compliance with study requirements. 2. History of allergic reactions to the study drugs or their analogs. 3. Failure to recover from any prior surgery within 4 weeks of study entry. 4. Pregnant or lactating. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry, for the duration of study participation and for at least 3 months after the last treatment. 5. Any treatment specific for tumor control within 3 weeks of study drugs; or within 2 weeks if cytotoxic agents were given weekly (within 6 wks for nitrosoureas or mitomycin C), or within 5 half-lives for target agents with half lives and pharmacodynamic effects lasting less than 5 days (that include but are not limited to erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents); or failure to recover from the toxic effect of any therapy prior to study entry. 6. Serious non-healing wound, ulcer, bone fracture (including abdominal fistula, gastrointestinal perforation or intra-abdominal abscess), or history of bleeding diathesis or coagulopathy. 7. History of radiotherapy to the abdominal and pelvic regions or history of multiple abdominal surgeries that contraindicates this protocol therapy. 8. Urine dipstick for proteinuria >/= 2+ (patients discovered to have >/= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate </= 1g of protein in 24 hours to be eligible). 9. Grade 2 or greater neuropathy, and history of brain or leptomeningeal metastases that significantly increase risks of intracranial bleeding. 10. All types of solid tumors are included. However, patients with significant metastases outside of abdomen and pelvis as well as any mass greater than 4 cm are excluded. Trial Lead Organizations/Sponsors M. D. Anderson Cancer Center at University of Texas
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Summary This study will assess the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin in patients with advanced solid tumors. Eligibility Criteria Inclusion Criteria:
Exclusion Criteria:
Trial Lead Organizations/Sponsors Pfizer Incorporated
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Sorafenib, Pemetrexed, and Cisplatin in Treating Patients With Advanced Solid Tumors Objectives Primary
Secondary
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
Patient Characteristics:
Trial Lead Organizations Masonic Cancer Center at University of Minnesota
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