A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.
NCT ID: NCT02021500
Last Updated: 2019-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2014-01-02
2015-04-16
Brief Summary
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Detailed Description
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* Vital Status
* Date of disease progression
* Subsequent anticancer therapy for pancreatic adenocarcinoma
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Patients previously enrolled in study CA046
No intervention is being given in this extension study which is gathering survival information on participants of study NCT 00844649 (Celgene study CA046) who were known to be alive as of March 2013)
ABI-007
No intervention is being given in this extension study which is gathering survival information on participants of study NCT 00844649 (Celgene study CA046) who were known to be alive as of March 2013)
Interventions
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ABI-007
No intervention is being given in this extension study which is gathering survival information on participants of study NCT 00844649 (Celgene study CA046) who were known to be alive as of March 2013)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Victoria Manax, MD
Role: STUDY_DIRECTOR
Celgene
Locations
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TGen Clinical Research Services
Scottsdale, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Pacific Shores Medical Group
Long Beach, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Florida Cancer Specialists
Englewood, Florida, United States
Florida Cancer Specialist
Tavares, Florida, United States
Indiana University
Indianapolis, Indiana, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Arena Oncology Associates
Lake Success, New York, United States
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
South Texas Oncology and Hematology (STOH)
San Antonio, Texas, United States
Fairfax-Northern Virginia Haematology-Oncology
Fairfax, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Froedtert and Medical College ID Clinic
Milwaukee, Wisconsin, United States
Macarthur Cancer Therapy Centre
Campbelltown, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
HOCA - the Wesley Clinic for Heamatology and Oncology
Auchenflower, Queensland, Australia
Mater Medical Center
South Brisbane, , Australia
Landesklinikum St. Pölten
Sankt Pölten, , Austria
Medizinische Universität Wien
Vienna, , Austria
Klinikum Wels-Grieskirchen GmbH
Wels, , Austria
Tom Baker Cancer Centre
Calgary, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Centre Hospsitalier Universitaire de Montreal - Notre Dame
Montreal, Quebec, Canada
Hôpital Beaujon
Clichy, , France
Hôpital Saint Antoine
Paris, , France
Kliniken Essen-Mitte
Essen, , Germany
LMU Klinikum der Universität München
München, , Germany
Ospedale San Raffaele S.r.l.
Milan, , Italy
Azienda Ospedaliera Niguarda Cà Granda
Milan, , Italy
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotundo, , Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, , Italy
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Municipal institution Multifield City Clinical Hospital #4 of Dnipropetrovsk Regional Council
Dnipropetrovsk, , Ukraine
Countries
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References
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Ramanathan RK, Goldstein D, Korn RL, Arena F, Moore M, Siena S, Teixeira L, Tabernero J, Van Laethem JL, Liu H, McGovern D, Lu B, Von Hoff DD. Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas. Ann Oncol. 2016 Apr;27(4):648-53. doi: 10.1093/annonc/mdw020. Epub 2016 Jan 22.
Chiorean EG, Von Hoff DD, Reni M, Arena FP, Infante JR, Bathini VG, Wood TE, Mainwaring PN, Muldoon RT, Clingan PR, Kunzmann V, Ramanathan RK, Tabernero J, Goldstein D, McGovern D, Lu B, Ko A. CA19-9 decrease at 8 weeks as a predictor of overall survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Ann Oncol. 2016 Apr;27(4):654-60. doi: 10.1093/annonc/mdw006. Epub 2016 Jan 22.
Goldstein D, Von Hoff DD, Moore M, Greeno E, Tortora G, Ramanathan RK, Macarulla T, Liu H, Pilot R, Ferrara S, Lu B. Development of peripheral neuropathy and its association with survival during treatment with nab-paclitaxel plus gemcitabine for patients with metastatic adenocarcinoma of the pancreas: A subset analysis from a randomised phase III trial (MPACT). Eur J Cancer. 2016 Jan;52:85-91. doi: 10.1016/j.ejca.2015.10.017. Epub 2015 Dec 1.
Portal A, Pernot S, Tougeron D, Arbaud C, Bidault AT, de la Fouchardiere C, Hammel P, Lecomte T, Dreanic J, Coriat R, Bachet JB, Dubreuil O, Marthey L, Dahan L, Tchoundjeu B, Locher C, Lepere C, Bonnetain F, Taieb J. Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after Folfirinox failure: an AGEO prospective multicentre cohort. Br J Cancer. 2015 Sep 29;113(7):989-95. doi: 10.1038/bjc.2015.328. Epub 2015 Sep 15.
Goldstein D, El-Maraghi RH, Hammel P, Heinemann V, Kunzmann V, Sastre J, Scheithauer W, Siena S, Tabernero J, Teixeira L, Tortora G, Van Laethem JL, Young R, Penenberg DN, Lu B, Romano A, Von Hoff DD. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. J Natl Cancer Inst. 2015 Jan 31;107(2):dju413. doi: 10.1093/jnci/dju413. Print 2015 Feb.
Vogel A, Pelzer U, Salah-Eddin AB, Koster W. First-line nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer from routine clinical practice. In Vivo. 2014 Nov-Dec;28(6):1135-40.
Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
Al-Hajeili M, Azmi AS, Choi M. Nab-paclitaxel: potential for the treatment of advanced pancreatic cancer. Onco Targets Ther. 2014 Feb 4;7:187-92. doi: 10.2147/OTT.S40705. eCollection 2014.
Tabernero J, Chiorean EG, Infante JR, Hingorani SR, Ganju V, Weekes C, Scheithauer W, Ramanathan RK, Goldstein D, Penenberg DN, Romano A, Ferrara S, Von Hoff DD. Prognostic factors of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Oncologist. 2015 Feb;20(2):143-50. doi: 10.1634/theoncologist.2014-0394. Epub 2015 Jan 12.
Chiorean EG, Von Hoff DD, Tabernero J, El-Maraghi R, Ma WW, Reni M, Harris M, Whorf R, Liu H, Li JS, Manax V, Romano A, Lu B, Goldstein D. Second-line therapy after nab-paclitaxel plus gemcitabine or after gemcitabine for patients with metastatic pancreatic cancer. Br J Cancer. 2016 Jul 12;115(2):188-94. doi: 10.1038/bjc.2016.185. Epub 2016 Jun 28.
Tehfe M, Dowden S, Kennecke H, El-Maraghi R, Lesperance B, Couture F, Letourneau R, Liu H, Romano A. nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial. Adv Ther. 2016 May;33(5):747-59. doi: 10.1007/s12325-016-0327-4. Epub 2016 Apr 16.
Scheithauer W, Ramanathan RK, Moore M, Macarulla T, Goldstein D, Hammel P, Kunzmann V, Liu H, McGovern D, Romano A, Von Hoff DD. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol. 2016 Jun;7(3):469-78. doi: 10.21037/jgo.2016.01.03.
Vogel A, Rommler-Zehrer J, Li JS, McGovern D, Romano A, Stahl M. Efficacy and safety profile of nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer treated to disease progression: a subanalysis from a phase 3 trial (MPACT). BMC Cancer. 2016 Oct 21;16(1):817. doi: 10.1186/s12885-016-2798-8.
Tabernero J, Kunzmann V, Scheithauer W, Reni M, Shiansong Li J, Ferrara S, Djazouli K. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial. Onco Targets Ther. 2017 Feb 2;10:591-596. doi: 10.2147/OTT.S124097. eCollection 2017.
Kunzmann V, Ramanathan RK, Goldstein D, Liu H, Ferrara S, Lu B, Renschler MF, Von Hoff DD. Tumor Reduction in Primary and Metastatic Pancreatic Cancer Lesions With nab-Paclitaxel and Gemcitabine: An Exploratory Analysis From a Phase 3 Study. Pancreas. 2017 Feb;46(2):203-208. doi: 10.1097/MPA.0000000000000742.
Other Identifiers
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ABI-007-PANC-CA046C
Identifier Type: -
Identifier Source: org_study_id
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