A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.

Pancreatic Cancer Clinical Trial

Official title:

MPACT Extension Study: Multicenter, Survival Data Collection in Subjects Previously Enrolled in Protocol CA046

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021500
• Other study ID #: ABI-007-PANC-CA046C
• Status: Completed
• Start date: January 2, 2014
• Est. completion date: April 16, 2015

Study information

• Verified date: October 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A study to collect survival data on patients previously enrolled in Abraxane pancreatic cancer study CA046.

Description:

A study to collect survival status of CA046 subjects who were know to be alive at the last report of vital status for CA046 - approximate timeframe - end of March, 2013. Once consent is given, on a quarterly basis, information on status will be collected to include:

• Vital Status

• Date of disease progression

• Subsequent anticancer therapy for pancreatic adenocarcinoma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 16, 2015
• Est. primary completion date: April 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Must have been enrolled in the CA046 study Must have been living at the time of the last survival follow-up (approximate timeframe - end of March, 2013) Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (ie, next of kin, legal representative) will be obtained prior to collection of data)

Exclusion Criteria:

• Consent refused for any reason

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Australia	HOCA - the Wesley Clinic for Heamatology and Oncology	Auchenflower	Queensland
Australia	Macarthur Cancer Therapy Centre	Campbelltown	New South Wales
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Mater Medical Center	South Brisbane
Austria	Landesklinikum St. Pölten	St. Pölten
Austria	Medizinische Universität Wien	Vienna
Austria	Klinikum Wels-Grieskirchen GmbH	Wels
Canada	Royal Victoria Regional Health Centre	Barrie	Ontario
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Centre Hospsitalier Universitaire de Montreal - Notre Dame	Montreal	Quebec
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
France	Hôpital Beaujon	Clichy
France	Hôpital Saint Antoine	Paris
Germany	Kliniken Essen-Mitte	Essen
Germany	LMU Klinikum der Universität München	Munchen
Italy	Azienda Ospedaliera Niguarda Cà Granda	Milano
Italy	Ospedale San Raffaele S.r.l.	Milano
Italy	Ospedale Casa Sollievo Della Sofferenza IRCCS	San Giovanni Rotundo
Italy	Azienda Ospedaliera Universitaria Integrata Di Verona	Verona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Ukraine	Municipal institution Multifield City Clinical Hospital #4 of Dnipropetrovsk Regional Council	Dnipropetrovsk
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Florida Cancer Specialists	Englewood	Florida
United States	Fairfax-Northern Virginia Haematology-Oncology	Fairfax	Virginia
United States	Indiana University	Indianapolis	Indiana
United States	Arena Oncology Associates	Lake Success	New York
United States	Pacific Shores Medical Group	Long Beach	California
United States	Froedtert and Medical College ID Clinic	Milwaukee	Wisconsin
United States	Tennessee Oncology PLLC	Nashville	Tennessee
United States	UPMC Cancer Pavillion	Pittsburgh	Pennsylvania
United States	Virginia Cancer Institute	Richmond	Virginia
United States	South Texas Oncology and Hematology (STOH)	San Antonio	Texas
United States	Mayo Clinic	Scottsdale	Arizona
United States	TGen Clinical Research Services	Scottsdale	Arizona
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Florida Cancer Specialist	Tavares	Florida
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany,  Italy,  Spain,  Ukraine, 

References & Publications (15)

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. Review. — View Citation

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. — View Citation

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. Erratum in: Br J Cancer. 2016 Oct 25;115(9):e13. — View Citation

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). pii: dju413. doi: 10.1093/jnci/dju413. Print 2015 Feb. — View Citation

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. — View Citation

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. — View Citation

Portal A, Pernot S, Tougeron D, Arbaud C, Bidault AT, de la Fouchardière C, Hammel P, Lecomte T, Dréanic J, Coriat R, Bachet JB, Dubreuil O, Marthey L, Dahan L, Tchoundjeu B, Locher C, Lepère 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Adv Ther. 2016 Nov 24;:. — View Citation

Vogel A, Pelzer U, Salah-Eddin AB, Köster 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. — View Citation

Vogel A, Römmler-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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Number of participants who survive	up to 3 years
Secondary	Disease progression	Date of disease progression and subsequent anticancer therapy for pancreatic adenocarcinoma other than that already recorded for subject while enrolled in CA046	up to 3 years