TriangleNCT00295503 · REGISTRY CONDITION SEARCH
Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2020-10-20
To estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- cisplatin, pemetrexed, and bevacizumab
- intervention Names
- Drug: bevacizumab
- Drug: cisplatin
- Drug: pemetrexed
- label
- 1
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- 1
- description
- 15 mg/kg IV every 3 weeks
- name
- bevacizumab
- type
- DRUG
- arm Group Labels
- 1
- description
- 75 mg/m2 IV every 3 weeks
- name
- cisplatin
- type
- DRUG
- arm Group Labels
- 1
- description
- 500 mg/m2 every 3 weeks
- name
- pemetrexed
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 53
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- This is the percentage of patients alive and progression-free at 6 months from initiation of treatment.
- measure
- Progression Free Survival Rate at 6 Months
- time Frame
- patients progression free at 6 months
- secondary Outcomes
- description
- response was assessed by the RECIST criteria (version 1.0). Per those criteria, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- measure
- Response Rate
- time Frame
- from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months
- description
- overall survival was measured from time of initiation of treatment to death from any cause
- measure
- Overall Survival
- time Frame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up 100 months
Full study description
- brief Summary
- To estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab
- detailed Description
- 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.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-855f9e27879241bdfdb1
- requested nct id
- NCT00295503
- primary nct id
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- source kind
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- payload
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- link basis
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- nct id
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- occurrences
- context exact
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- end
- 11
- exact text
- NCT00295503
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Malignant Mesothelioma
- query disease state id
- ds-malignant-mesothelioma
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-malignant-mesothelioma-000.json
- source file sha256
- 0a018dbf1aa46f57978b6d16aa19b94d76d6d65cf1e297e889c8e599fef1fab1
- source json pointer
- /studies/22/protocolSection/identificationModule/nctId
- source kind
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- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 6a5bce012143803a64806add930bf45de37a50dbf2d93294d10fb8a048e8f80d
Preserved source evidence · Not medical advice