Trial Outcomes & Findings for Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma (NCT NCT02611037)

Last Updated: 2025-12-18

Results Overview

Disease control rate of transarterial chemoperfusion treatment with cisplatin, methotrexate and gemcitabine in patients with unresectable malignant pleural mesothelioma using modified Response Evaluation Criteria in Solid Tumors (RECIST) for mesothelioma. DCR provided as percentage of participants with partial response + percentage of participants with stable disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2025-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Chemoperfusion -Lead In Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin. Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2). Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine.	Chemoperfusion - Open Label Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA.
Overall Study STARTED	7	27
Overall Study COMPLETED	5	27
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemoperfusion -Lead In Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin. Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2). Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine.	Chemoperfusion - Open Label Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA.
Overall Study Withdrawal prior to treatment	2	0

Baseline Characteristics

Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemoperfusion + Questionnaire n=34 Participants Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin. Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2). Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine. Lung Cancer Symptom Scale for Mesothelioma Questionnaire: Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.
Age, Categorical <=18 years	0 Participants n=47 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=47 Participants
Age, Categorical >=65 years	30 Participants n=47 Participants
Sex: Female, Male Female	5 Participants n=47 Participants
Sex: Female, Male Male	29 Participants n=47 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=47 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=47 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=47 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=47 Participants
Race (NIH/OMB) Asian	0 Participants n=47 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=47 Participants
Race (NIH/OMB) Black or African American	0 Participants n=47 Participants
Race (NIH/OMB) White	34 Participants n=47 Participants
Race (NIH/OMB) More than one race	0 Participants n=47 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=47 Participants
Region of Enrollment United States	34 participants n=47 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: All evaluable participants. Study patients cannot be analyzed separately. No dose limiting toxicities observed, therefore all participants received same dosing.

Outcome measures

Outcome measures
Measure	Chemoperfusion + Questionnaire n=32 Participants Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin. Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2). Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine. Lung Cancer Symptom Scale for Mesothelioma Questionnaire: Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.
Disease Control Rate (DCR)	75 percentage of participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: All evaluable participants. Study patients cannot be analyzed separately. No dose limiting toxicities observed, therefore all participants received same dosing.

Overall survival defined as the time from the first day of transarterial chemoperfusion treatment to death.

Outcome measures

Outcome measures
Measure	Chemoperfusion + Questionnaire n=32 Participants Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin. Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2). Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine. Lung Cancer Symptom Scale for Mesothelioma Questionnaire: Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.
Overall Survival (OS)	8.9 months Interval 5.7 to 15.0

SECONDARY outcome

Timeframe: Up to 3 years

Population: All evaluable participants. Study patients cannot be analyzed separately. No dose limiting toxicities observed, therefore all participants received same dosing.

Progression free survival defined as the time from the first day of transarterial chemoperfusion treatment to disease progression based on imaging findings using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for mesothelioma. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Outcome measures
Measure	Chemoperfusion + Questionnaire n=32 Participants Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin. Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2). Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine. Lung Cancer Symptom Scale for Mesothelioma Questionnaire: Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.
Progression Free Survival (PFS)	4.7 months Interval 2.5 to 7.4

SECONDARY outcome

Timeframe: Up to 3 years

Population: All evaluable participants. Study patients cannot be analyzed separately. No dose limiting toxicities observed, therefore all participants received same dosing.

Safety was assessed by monitoring adverse events and serious adverse events; the association with study treatment was assessed, and severity graded using Common Terminology Criteria for Adverse Events (CTCAE) v.4.03. Number of events that were Possible, Probable or Definitely related to study treatment.

Outcome measures

Outcome measures
Measure	Chemoperfusion + Questionnaire n=32 Participants Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin. Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2). Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine. Lung Cancer Symptom Scale for Mesothelioma Questionnaire: Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.
Occurrence of Treatment Related Toxicity	32 related adverse events

SECONDARY outcome

Timeframe: Up to 3 years

Population: Quality of life questionnaires were not collected, therefore this measure cannot be analyzed.

Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire. Mesothelioma Symptom Scale includes 7 categories to rate on a scale of 1 to 10 regarding severity of symptoms during the last 24 hours. A higher number indicates more severe symptoms.

Outcome measures

Outcome data not reported

Adverse Events

Chemoperfusion - Lead In

Serious events: 2 serious events

Other events: 5 other events

Deaths: 2 deaths

Chemoperfusion - Open Label

Serious events: 7 serious events

Other events: 25 other events

Deaths: 21 deaths

Serious adverse events

Other adverse events

Additional Information

Bela Kis, MD, PhD

Moffit Cancer Center

Phone: 813-745-8425

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Chemoperfusion - Lead In n=5 participants at risk Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin. Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2). Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine.	Chemoperfusion - Open Label n=25 participants at risk Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA
Cardiac disorders Atrial fibrillation	20.0% 1/5 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	8.0% 2/25 • Number of events 2 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
General disorders Fatigue	20.0% 1/5 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	0.00% 0/25 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Metabolism and nutrition disorders Hypomagnesemia	20.0% 1/5 • Number of events 3 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	0.00% 0/25 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Respiratory, thoracic and mediastinal disorders Dyspena	40.0% 2/5 • Number of events 5 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	20.0% 1/5 • Number of events 2 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	4.0% 1/25 • Number of events 3 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
General disorders Edema limbs	20.0% 1/5 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	0.00% 0/25 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Infections and infestations Urinary tract infection	20.0% 1/5 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	0.00% 0/25 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Respiratory, thoracic and mediastinal disorders Pneumonia	20.0% 1/5 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Vascular disorders Thromboembolic event	20.0% 1/5 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	0.00% 0/25 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
General disorders Fever	0.00% 0/5 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Gastrointestinal disorders Esophageal perforation	0.00% 0/5 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	4.0% 1/25 • Number of events 2 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Nervous system disorders Stroke	20.0% 1/5 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	0.00% 0/25 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Infections and infestations Lung infection	20.0% 1/5 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	0.00% 0/25 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	20.0% 1/5 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	20.0% 1/5 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	0.00% 0/25 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Gastrointestinal disorders Nausea	0.00% 0/5 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Gastrointestinal disorders Vomiting	0.00% 0/5 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Infections and infestations Upper respiratory infection	0.00% 0/5 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
General disorders Non-cardiac chest pain	0.00% 0/5 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.