A phase II evaluation of elesclomol sodium and weekly paclitaxel in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube or primary peritoneal cancer: An NRG oncology/gynecologic oncology group study

Preclinical data suggest elesclomol increases oxidative stress and enhances sensitivity to cytotoxic agents. The objective of this prospective multicenter phase 2 trial was to estimate the activity of IV elesclomol plus weekly paclitaxel in patients with platinum-resistant recurrent ovarian, tubal o...

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Published in:	Gynecologic oncology Vol. 151; no. 3; pp. 422 - 427
Main Authors:	Monk, Bradley J., Kauderer, James T., Moxley, Katherine M., Bonebrake, Albert J., Dewdney, Summer B., Secord, Angeles Alvarez, Ueland, Frederick R., Johnston, Carolyn M., Aghajanian, Carol
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01.12.2018
Subjects:	Adult Aged Aged, 80 and over Antineoplastic Agents, Phytogenic - pharmacology Antineoplastic Agents, Phytogenic - therapeutic use Antineoplastic Combined Chemotherapy Protocols - pharmacology Antineoplastic Combined Chemotherapy Protocols - therapeutic use Clinical trial Elesclomol Fallopian Tube Neoplasms - drug therapy Fallopian Tube Neoplasms - pathology Female Humans Hydrazines - pharmacology Hydrazines - therapeutic use Middle Aged Ovarian cancer Ovarian Neoplasms - drug therapy Ovarian Neoplasms - pathology Paclitaxel - pharmacology Paclitaxel - therapeutic use Peritoneal Neoplasms - drug therapy Peritoneal Neoplasms - pathology Clinical trial Elesclomol Ovarian cancer
ISSN:	0090-8258, 1095-6859, 1095-6859
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Abstract	Preclinical data suggest elesclomol increases oxidative stress and enhances sensitivity to cytotoxic agents. The objective of this prospective multicenter phase 2 trial was to estimate the activity of IV elesclomol plus weekly paclitaxel in patients with platinum-resistant recurrent ovarian, tubal or peritoneal cancer through the frequency of objective tumor responses (ORR). Patients with measurable disease, acceptable organ function, performance status ≤ 2, and one prior platinum containing regimen were eligible. A two-stage design was utilized with a target sample size of 22 and 30 subjects, respectively. Prior Gynecologic Oncology Group studies within the same population involving single agent taxanes showed an ORR of approximately (20%) and served as a historical control for direct comparison. The present study was designed to determine if the regimen had an ORR of ≥40% with 90% power. Fifty-eight patients were enrolled, of whom 2 received no study treatment and were inevaluable. The median number of cycles was 3 (268 total cycles, range 1–18). The number of patients responding was 11 (19.6%; 90% CI 11.4% to 30.4%) with one complete response. The median progression-free survival and overall survival was 3.6 months and 13.3 months, respectively. The median ORR duration was 9.2 months. Percentages of subjects with grade 3 toxicity included: Neutropenia 9%; anemia 5%; metabolic 5%; nausea 4%; infection 4%; neurologic (mostly neuropathy) 4%; and vascular (mostly thromboembolism) 4%. There were no grade 4 toxicities reported. This combination was well tolerated but is unworthy of further investigation based on the proportion responding [ClinicalTrials.gov Identifier: NCT00888615]. •Elesclomol increases reactive oxygen species and enhances the efficacy of chemotherapy in preclinical models.•There is no added clinical benefit to paclitaxel when elesclomol is added to treatment of recurrent ovarian cancer.•The combination of paclitaxel and elesclomol is well tolerated.
AbstractList	Preclinical data suggest elesclomol increases oxidative stress and enhances sensitivity to cytotoxic agents. The objective of this prospective multicenter phase 2 trial was to estimate the activity of IV elesclomol plus weekly paclitaxel in patients with platinum-resistant recurrent ovarian, tubal or peritoneal cancer through the frequency of objective tumor responses (ORR). Patients with measurable disease, acceptable organ function, performance status ≤ 2, and one prior platinum containing regimen were eligible. A two-stage design was utilized with a target sample size of 22 and 30 subjects, respectively. Prior Gynecologic Oncology Group studies within the same population involving single agent taxanes showed an ORR of approximately (20%) and served as a historical control for direct comparison. The present study was designed to determine if the regimen had an ORR of ≥40% with 90% power. Fifty-eight patients were enrolled, of whom 2 received no study treatment and were inevaluable. The median number of cycles was 3 (268 total cycles, range 1-18). The number of patients responding was 11 (19.6%; 90% CI 11.4% to 30.4%) with one complete response. The median progression-free survival and overall survival was 3.6 months and 13.3 months, respectively. The median ORR duration was 9.2 months. Percentages of subjects with grade 3 toxicity included: Neutropenia 9%; anemia 5%; metabolic 5%; nausea 4%; infection 4%; neurologic (mostly neuropathy) 4%; and vascular (mostly thromboembolism) 4%. There were no grade 4 toxicities reported. This combination was well tolerated but is unworthy of further investigation based on the proportion responding [ClinicalTrials.gov Identifier: NCT00888615]. Preclinical data suggest elesclomol increases oxidative stress and enhances sensitivity to cytotoxic agents. The objective of this prospective multicenter phase 2 trial was to estimate the activity of IV elesclomol plus weekly paclitaxel in patients with platinum-resistant recurrent ovarian, tubal or peritoneal cancer through the frequency of objective tumor responses (ORR).OBJECTIVEPreclinical data suggest elesclomol increases oxidative stress and enhances sensitivity to cytotoxic agents. The objective of this prospective multicenter phase 2 trial was to estimate the activity of IV elesclomol plus weekly paclitaxel in patients with platinum-resistant recurrent ovarian, tubal or peritoneal cancer through the frequency of objective tumor responses (ORR).Patients with measurable disease, acceptable organ function, performance status ≤ 2, and one prior platinum containing regimen were eligible. A two-stage design was utilized with a target sample size of 22 and 30 subjects, respectively. Prior Gynecologic Oncology Group studies within the same population involving single agent taxanes showed an ORR of approximately (20%) and served as a historical control for direct comparison. The present study was designed to determine if the regimen had an ORR of ≥40% with 90% power.METHODSPatients with measurable disease, acceptable organ function, performance status ≤ 2, and one prior platinum containing regimen were eligible. A two-stage design was utilized with a target sample size of 22 and 30 subjects, respectively. Prior Gynecologic Oncology Group studies within the same population involving single agent taxanes showed an ORR of approximately (20%) and served as a historical control for direct comparison. The present study was designed to determine if the regimen had an ORR of ≥40% with 90% power.Fifty-eight patients were enrolled, of whom 2 received no study treatment and were inevaluable. The median number of cycles was 3 (268 total cycles, range 1-18). The number of patients responding was 11 (19.6%; 90% CI 11.4% to 30.4%) with one complete response. The median progression-free survival and overall survival was 3.6 months and 13.3 months, respectively. The median ORR duration was 9.2 months. Percentages of subjects with grade 3 toxicity included: Neutropenia 9%; anemia 5%; metabolic 5%; nausea 4%; infection 4%; neurologic (mostly neuropathy) 4%; and vascular (mostly thromboembolism) 4%. There were no grade 4 toxicities reported.RESULTSFifty-eight patients were enrolled, of whom 2 received no study treatment and were inevaluable. The median number of cycles was 3 (268 total cycles, range 1-18). The number of patients responding was 11 (19.6%; 90% CI 11.4% to 30.4%) with one complete response. The median progression-free survival and overall survival was 3.6 months and 13.3 months, respectively. The median ORR duration was 9.2 months. Percentages of subjects with grade 3 toxicity included: Neutropenia 9%; anemia 5%; metabolic 5%; nausea 4%; infection 4%; neurologic (mostly neuropathy) 4%; and vascular (mostly thromboembolism) 4%. There were no grade 4 toxicities reported.This combination was well tolerated but is unworthy of further investigation based on the proportion responding [ClinicalTrials.gov Identifier: NCT00888615].CONCLUSIONSThis combination was well tolerated but is unworthy of further investigation based on the proportion responding [ClinicalTrials.gov Identifier: NCT00888615]. Preclinical data suggest elesclomol increases oxidative stress and enhances sensitivity to cytotoxic agents. The objective of this prospective multicenter phase 2 trial was to estimate the activity of IV elesclomol plus weekly paclitaxel in patients with platinum-resistant recurrent ovarian, tubal or peritoneal cancer through the frequency of objective tumor responses (ORR). Patients with measurable disease, acceptable organ function, performance status ≤ 2, and one prior platinum containing regimen were eligible. A two-stage design was utilized with a target sample size of 22 and 30 subjects, respectively. Prior Gynecologic Oncology Group studies within the same population involving single agent taxanes showed an ORR of approximately (20%) and served as a historical control for direct comparison. The present study was designed to determine if the regimen had an ORR of ≥40% with 90% power. Fifty-eight patients were enrolled, of whom 2 received no study treatment and were inevaluable. The median number of cycles was 3 (268 total cycles, range 1–18). The number of patients responding was 11 (19.6%; 90% CI 11.4% to 30.4%) with one complete response. The median progression-free survival and overall survival was 3.6 months and 13.3 months, respectively. The median ORR duration was 9.2 months. Percentages of subjects with grade 3 toxicity included: Neutropenia 9%; anemia 5%; metabolic 5%; nausea 4%; infection 4%; neurologic (mostly neuropathy) 4%; and vascular (mostly thromboembolism) 4%. There were no grade 4 toxicities reported. This combination was well tolerated but is unworthy of further investigation based on the proportion responding [ClinicalTrials.gov Identifier: NCT00888615]. •Elesclomol increases reactive oxygen species and enhances the efficacy of chemotherapy in preclinical models.•There is no added clinical benefit to paclitaxel when elesclomol is added to treatment of recurrent ovarian cancer.•The combination of paclitaxel and elesclomol is well tolerated.
Author	Aghajanian, Carol Johnston, Carolyn M. Secord, Angeles Alvarez Monk, Bradley J. Bonebrake, Albert J. Dewdney, Summer B. Moxley, Katherine M. Kauderer, James T. Ueland, Frederick R.
AuthorAffiliation	8. University of Michigan Health System-Cancer Center; Ann Arbor, MI johnstob@med.umich.edu 1. Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St. Joseph Hospital, Phoenix, AZ Bradley.Monk@usoncology.com 3. University of Oklahoma Health Sciences Center; Oklahoma City, OK katherine-moxley@ouhsc.edu 4. Cancer Research for the Ozarks-Cox Health; Ferrell Duncan Clinic GYN-ONC; Springfield, MO 65807 albert.bonebrake@coxhealth.com 7. University of Kentucky; Lexington, KY 40536 fuela0@uky.edu 2. NRG Oncology; Clinical Trial Development Division; Biostatistics & Bioinformatics; Roswell Park; Buffalo, NY jkauderer@gogstats.org 5. Rush University Medical Center; Chicago, IL 60612 summer_dewdney@rush.edu 6. Duke University Medical Center; Duke Cancer Institute; Durham, NC angeles.secord@duke.edu 9. Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY aghajanc@mskcc.org
AuthorAffiliation_xml	– name: 5. Rush University Medical Center; Chicago, IL 60612 summer_dewdney@rush.edu – name: 6. Duke University Medical Center; Duke Cancer Institute; Durham, NC angeles.secord@duke.edu – name: 3. University of Oklahoma Health Sciences Center; Oklahoma City, OK katherine-moxley@ouhsc.edu – name: 7. University of Kentucky; Lexington, KY 40536 fuela0@uky.edu – name: 8. University of Michigan Health System-Cancer Center; Ann Arbor, MI johnstob@med.umich.edu – name: 1. Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St. Joseph Hospital, Phoenix, AZ Bradley.Monk@usoncology.com – name: 4. Cancer Research for the Ozarks-Cox Health; Ferrell Duncan Clinic GYN-ONC; Springfield, MO 65807 albert.bonebrake@coxhealth.com – name: 9. Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY aghajanc@mskcc.org – name: 2. NRG Oncology; Clinical Trial Development Division; Biostatistics & Bioinformatics; Roswell Park; Buffalo, NY jkauderer@gogstats.org
Author_xml	– sequence: 1 givenname: Bradley J. surname: Monk fullname: Monk, Bradley J. email: Bradley.Monk@usoncology.com organization: Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St. Joseph Hospital, Phoenix, AZ, USA – sequence: 2 givenname: James T. surname: Kauderer fullname: Kauderer, James T. email: jkauderer@gogstats.org organization: NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park, Buffalo, NY, USA – sequence: 3 givenname: Katherine M. surname: Moxley fullname: Moxley, Katherine M. email: katherine-moxley@ouhsc.edu organization: University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA – sequence: 4 givenname: Albert J. surname: Bonebrake fullname: Bonebrake, Albert J. email: albert.bonebrake@coxhealth.com organization: Cancer Research for the Ozarks-Cox Health. Ferrell Duncan Clinic GYN-ONC, Springfield, MO 65807, USA – sequence: 5 givenname: Summer B. surname: Dewdney fullname: Dewdney, Summer B. email: summer_dewdney@rush.edu organization: Rush University Medical Center, Chicago, IL 60612, USA – sequence: 6 givenname: Angeles Alvarez surname: Secord fullname: Secord, Angeles Alvarez email: angeles.secord@duke.edu organization: Duke University Medical Center, Duke Cancer Institute, Durham, NC, USA – sequence: 7 givenname: Frederick R. surname: Ueland fullname: Ueland, Frederick R. email: fuela0@uky.edu organization: University of Kentucky, Lexington, KY 40536, USA – sequence: 8 givenname: Carolyn M. surname: Johnston fullname: Johnston, Carolyn M. email: johnstob@med.umich.edu organization: University of Michigan Health System-Cancer Center, Ann Arbor, MI, USA – sequence: 9 givenname: Carol surname: Aghajanian fullname: Aghajanian, Carol email: aghajanc@mskcc.org organization: Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY, USA
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Notes	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 AUTHOR CONTRIBUTIONS All authors provided data, were involved in writing, revision, and approved the final manuscript. James Kauderer performed the statistical analyses of this study.
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Snippet	Preclinical data suggest elesclomol increases oxidative stress and enhances sensitivity to cytotoxic agents. The objective of this prospective multicenter...
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SubjectTerms	Adult Aged Aged, 80 and over Antineoplastic Agents, Phytogenic - pharmacology Antineoplastic Agents, Phytogenic - therapeutic use Antineoplastic Combined Chemotherapy Protocols - pharmacology Antineoplastic Combined Chemotherapy Protocols - therapeutic use Clinical trial Elesclomol Fallopian Tube Neoplasms - drug therapy Fallopian Tube Neoplasms - pathology Female Humans Hydrazines - pharmacology Hydrazines - therapeutic use Middle Aged Ovarian cancer Ovarian Neoplasms - drug therapy Ovarian Neoplasms - pathology Paclitaxel - pharmacology Paclitaxel - therapeutic use Peritoneal Neoplasms - drug therapy Peritoneal Neoplasms - pathology
Title	A phase II evaluation of elesclomol sodium and weekly paclitaxel in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube or primary peritoneal cancer: An NRG oncology/gynecologic oncology group study
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