Trial Outcomes & Findings for Trimodal Lung-Sparing Treatment of Pleural Mesothelioma (NCT NCT00859495)

Results Overview

To determine the feasibility of multimodal lung sparing regimen. Intrapleural chemotherapy (12 weeks) will be administered within two weeks after surgery. Approximately 30 days post last dose of chemotherapy (+/- 14 days), the patient should be reassessed for resolution of any treatment-related toxicity which may have occurred during the course of study participation.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

20 weeks

Results posted on

2020-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Multimodal Lung Sparing Regimen Intrapleural chemotherapy plus systemic chemotherapy: Thoracoscopy to implant two intrapleural catheters followed by intrapleural chemotherapy with doxorubicin and cisplatin (weeks 1, 2, 4, 5, 7, and 8). Systemic chemotherapy treatments with cisplatin and pemetrexed during weeks 3, 6, and 9. Intrapleural radiotherapy with P-32 will be given 3 weeks after last dose of chemotherapy and 11 to 12 weeks after initial thoracoscopy. Doxorubicin: A medication used in cancer chemotherapy, derived by chemical semisynthesis from a bacterial species. Cisplatin: Platinum-based antineoplastic Pemetrexed: Folate Analog Metabolic Inhibitor Radiotherapy: Standard procedure given 3 weeks after last dose of chemotherapy
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trimodal Lung-Sparing Treatment of Pleural Mesothelioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multimodal Lung Sparing Regimen n=9 Participants Intrapleural chemotherapy plus systemic chemotherapy: Thoracoscopy to implant two intrapleural catheters followed by intrapleural chemotherapy with doxorubicin and cisplatin (weeks 1, 2, 4, 5, 7, and 8). Systemic chemotherapy treatments with cisplatin and pemetrexed during weeks 3, 6, and 9. Intrapleural radiotherapy with P-32 will be given 3 weeks after last dose of chemotherapy and 11 to 12 weeks after initial thoracoscopy. Doxorubicin: A medication used in cancer chemotherapy, derived by chemical semisynthesis from a bacterial species. Cisplatin: Platinum-based antineoplastic Pemetrexed: Folate Analog Metabolic Inhibitor Radiotherapy: Standard procedure given 3 weeks after last dose of chemotherapy
Age, Customized 18-65 years	7 Participants n=39 Participants
Age, Customized > 65 years	2 Participants n=39 Participants
Sex/Gender, Customized Non-specific	0 Participants n=39 Participants
Race/Ethnicity, Customized Caucasian	8 Participants n=39 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=39 Participants
Region of Enrollment United States	9 participants n=39 Participants

PRIMARY outcome

Timeframe: 20 weeks

To determine the feasibility of multimodal lung sparing regimen. Intrapleural chemotherapy (12 weeks) will be administered within two weeks after surgery. Approximately 30 days post last dose of chemotherapy (+/- 14 days), the patient should be reassessed for resolution of any treatment-related toxicity which may have occurred during the course of study participation.

Outcome measures

Outcome measures
Measure	Multimodal Lung Sparing Regimen n=9 Participants Intrapleural chemotherapy plus systemic chemotherapy: Thoracoscopy to implant two intrapleural catheters followed by intrapleural chemotherapy with doxorubicin and cisplatin (weeks 1, 2, 4, 5, 7, and 8). Systemic chemotherapy treatments with cisplatin and pemetrexed during weeks 3, 6, and 9. Intrapleural radiotherapy with P-32 will be given 3 weeks after last dose of chemotherapy and 11 to 12 weeks after initial thoracoscopy. Doxorubicin: A medication used in cancer chemotherapy, derived by chemical semisynthesis from a bacterial species. Cisplatin: Platinum-based antineoplastic Pemetrexed: Folate Analog Metabolic Inhibitor Radiotherapy: Standard procedure given 3 weeks after last dose of chemotherapy
Number of Subjects Who Were Able to Complete Trimodal Therapy (Combination of Surgery, Intrapleural and Systemic Chemotherapy and P-32 Radiotherapy).	9 Participants

Adverse Events

Multimodal Lung Sparing Regimen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Taub, MD

Columbia University

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place