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

NCT02021500 | Completed

• 1 other identifier: ABI-007-PANC-CA046C
• Study Type: observational
• Target: 40
• Locations: 8 countries
• Sites: 36

Brief Summary

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Number of participants who survive

  up to 3 years

Secondary Outcomes (1)

• Disease progression

  up to 3 years

Study Arms (1)

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)

Drug: ABI-007

Interventions

ABI-007 DRUG

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)

Patients previously enrolled in study CA046

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients previously enrolled in study CA046

You may qualify if:

• 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)

You may not qualify if:

• Consent refused for any reason

Sponsors & Collaborators

• Celgene: lead

Study Sites (39)

TGen Clinical Research Services

Scottsdale, Arizona, 85004, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259-5499, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Florida Cancer Specialists

Englewood, Florida, 34223, United States

Location

Florida Cancer Specialist

Tavares, Florida, 32778, United States

Location

Indiana University

Indianapolis, Indiana, 46202-5149, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Arena Oncology Associates

Lake Success, New York, 11042, United States

Location

UPMC Cancer Pavillion

Pittsburgh, Pennsylvania, 15232, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

Location

South Texas Oncology and Hematology (STOH)

San Antonio, Texas, 78229, United States

Location

Fairfax-Northern Virginia Haematology-Oncology

Fairfax, Virginia, 22033, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Froedtert and Medical College ID Clinic

Milwaukee, Wisconsin, 53226, United States

Location

Macarthur Cancer Therapy Centre

Campbelltown, New South Wales, 2560, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

HOCA - the Wesley Clinic for Heamatology and Oncology

Auchenflower, Queensland, 4066, Australia

Location

Mater Medical Center

South Brisbane, 4101, Australia

Location

Landesklinikum St. Pölten

Sankt Pölten, 3100, Austria

Location

Medizinische Universität Wien

Vienna, 1090, Austria

Location

Klinikum Wels-Grieskirchen GmbH

Wels, 4600, Austria

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M6M2, Canada

Location

Centre Hospsitalier Universitaire de Montreal - Notre Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Hôpital Beaujon

Clichy, 92118, France

Location

Hôpital Saint Antoine

Paris, 75571, France

Location

Kliniken Essen-Mitte

Essen, 45136, Germany

Location

LMU Klinikum der Universität München

München, 81377:, Germany

Location

Ospedale San Raffaele S.r.l.

Milan, 20133, Italy

Location

Azienda Ospedaliera Niguarda Cà Granda

Milan, 20162, Italy

Location

Ospedale Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotundo, 71013, Italy

Location

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, 37134, Italy

Location

Hospital Universitari Vall d'Hebron

Barcelona, 8035, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Municipal institution Multifield City Clinical Hospital #4 of Dnipropetrovsk Regional Council

Dnipropetrovsk, 49102, Ukraine

Location

Related Publications (15)

• 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.

  PMID: 26802153 BACKGROUND

• 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.

  PMID: 26802160 BACKGROUND

• 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.

  PMID: 26655559 BACKGROUND

• 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.

  PMID: 26372701 BACKGROUND

• 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.

  PMID: 25638248 BACKGROUND

• 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.

  PMID: 25398812 BACKGROUND

• 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.

  PMID: 24131140 BACKGROUND

• 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.

  PMID: 24523592 BACKGROUND

• 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.

  PMID: 25582141 BACKGROUND

• 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.

  PMID: 27351217 BACKGROUND

• 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.

  PMID: 27085323 BACKGROUND

• 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.

  PMID: 27284481 BACKGROUND

• 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.

  PMID: 27769210 BACKGROUND

• 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.

  PMID: 28203092 BACKGROUND

• 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.

  PMID: 27841795 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Victoria Manax, MD

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: January 2, 2014
• Primary Completion: April 16, 2015
• Study Completion: April 16, 2015
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

FR (2); DE (2); ES (3); IT (4); AU (4); UA (1); CA (4); US (16)