AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer

NCT00219557 | Completed Phase 2 Results

• 2 other identifiers: A40610162005-000053-30
• Study Type: interventional
• Target: 111
• Locations: 8 countries
• Sites: 38

Brief Summary

This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib \[AG-013736\] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.

Conditions

Pancreatic Neoplasms

Keywords

Randomized Phase 2 Study of AG-013736 in Combination with Gemcitabine versus Gemcitabine Alone in Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Time in days from randomization to date of death due to any cause. OS was calculated as the death date minus the date of randomization plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

  Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant

Secondary Outcomes (16)

• Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)

  Phase 1 baseline up to Week 4

• Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)

  Phase 1 Baseline up to Week 4

• Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)

  0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hours (hr) post-dose on Day 15 of Phase 1 Cycle 1

• Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736)

  0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)

  0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1

Study Arms (2)

Gemcitabine

ACTIVE COMPARATOR

Drug: Gemcitabine

Axitinib [AG-013736] plus gemcitabine

EXPERIMENTAL

Drug: AG-013736; Drug: Gemcitabine

Interventions

Gemcitabine DRUG

Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks

Gemcitabine

AG-013736 DRUG

Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks.

Axitinib [AG-013736] plus gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with advanced (localized but surgically unresectable or metastatic) histologically/cytologically proven epithelial cancer of the exocrine pancreas
• no prior therapy for metastatic disease

You may not qualify if:

• patients with locally advanced disease who are candidates for radiation therapy.
• uncontrolled brain metastases (a controlled brain metastasis must be previously treated, asymptomatic, and without growth for 4 months)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (38)

East Bay Medical Oncology/Hematology Medical Associates Inc.

Antioch, California, 94509, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Bay Area Cancer Research Group

Concord, California, 94520, United States

Location

East Bay Medical Oncology/Hematology Medical Associates, Inc.

Concord, California, 94520, United States

Location

Hematology Oncology, P.C.

Stamford, Connecticut, 06902-3628, United States

Location

Jackson Memorial Hospital & Clinics

Miami, Florida, 33136, United States

Location

University of Miami Hospital & clinics

Miami, Florida, 33136, United States

Location

H Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612-9497, United States

Location

Maine Center for Cancer Medicine and Blood Disorders

Biddeford, Maine, 04005, United States

Location

Maine Center for Cancer Medicine and Blood Disorders

Brunswick, Maine, 04011, United States

Location

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, 04074, United States

Location

Arch Medical Services, Inc. d/b/a The Center for Cancer Care and Research

St Louis, Missouri, 63141, United States

Location

Arch Medical Services, Inc. d/b/a The Center for Cancer Care and Research

Washington, Missouri, 63090, United States

Location

Southeast Nebraska Cancer Center, Southeast Nebraska Hematology and Oncology Consultants, P.C.

Lincoln, Nebraska, 68510, United States

Location

Piedmont Hematology Oncology Association

Winston-Salem, North Carolina, 27103, United States

Location

Piedmont Hematology Oncology Associates

Winston-Salem, North Carolina, 27292, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Universitair Ziekenhuis Gent/Dienst Gastroenterologie

Ghent, 9000, Belgium

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R2H 2A6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Sault Area Hospital

Sault Ste. Marie, Ontario, P6A 2C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM, Hopital Saint-Luc

Montreal, Quebec, H2X 3J4, Canada

Location

Service Oncologie Medicale

Saint-Herblain, Saint Herblain Cedex, 44805, France

Location

Hopital La Timone

Marseille, 13005, France

Location

Hopital de la Pitie Salpetriere

Paris, 75651, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Medizinische Klinik mit Schwerpunkt Haematologie und Onkologie, Charité-Universitaetsmedizin Berlin

Berlin, 13353, Germany

Location

Fondazione IRCCS, Istituto Nazionale Tumori, Oncologia Medica B

Milan, 20133, Italy

Location

Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria

Roma, 00168, Italy

Location

Hospital Universitario Vall D´Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Cancer Research Uk Clinical Centre

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Department of Cancer Studies & Molecular Medicine

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Western General Hospitals Nhs Trust

Edinburgh, EH4 2XU, United Kingdom

Location

Hammersmith Hospital

London, W12 OHS, United Kingdom

Location

Related Publications (1)

• Spano JP, Chodkiewicz C, Maurel J, Wong R, Wasan H, Barone C, Letourneau R, Bajetta E, Pithavala Y, Bycott P, Trask P, Liau K, Ricart AD, Kim S, Rixe O. Efficacy of gemcitabine plus axitinib compared with gemcitabine alone in patients with advanced pancreatic cancer: an open-label randomised phase II study. Lancet. 2008 Jun 21;371(9630):2101-8. doi: 10.1016/S0140-6736(08)60661-3. Epub 2008 May 29.

  PMID: 18514303 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Axitinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Population pharmacokinetics was not presented, as the data was not available for the single study and data of other axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: July 5, 2005
• Primary Completion: March 14, 2008
• Study Completion: March 14, 2008
• Last Updated: May 14, 2019
• Results First Posted: August 24, 2012

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (17); CA (6); GB (4); IT (2); ES (3); DE (1); FR (4); BE (1)