A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.

NCT00600821 | Completed Phase 2 Results DMC

• 1 other identifier: A4061030
• Study Type: interventional
• Target: 118
• Locations: 6 countries
• Sites: 44

Brief Summary

To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated.

Conditions

Non-Small-Cell Lung Carcinoma; Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Time in months from start of study treatment to first randomization date of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").

  Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years

Secondary Outcomes (10)

• Overall Survival (OS)

  Baseline, every 6 weeks until death or bimonthly after final study visit (up to 2.75 years)

• Percentage of Participants With Objective Response (OR)

  Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years

• Duration of Response (DR)

  Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years

• Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)

  Pre-dose, 1 to 2 hours post-dose on Cycle 2 of Day 1 and Cycle 3 of Day 1

• European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score

  Day (D) 1 of every cycle (C) then every 3 weeks until final study visit (up to 2.75 years)

Other Outcomes (1)

• Plasma Concentration Change in the Uridine Diphosphate Glucuronosyltransferase 1A1 (UGT1A1) Genotype

  Baseline (Day 1 of Cycle 1)

Study Arms (2)

B

ACTIVE COMPARATOR

Bevacizumab will be administered in combination with carboplatin and paclitaxel.

Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel

A

EXPERIMENTAL

AG-013736 will be administered in combination with carboplatin and paclitaxel.

Drug: AG-013736 (axitinib); Drug: Carboplatin; Drug: Paclitaxel

Interventions

Bevacizumab DRUG

Bevacizumab is available as 100 and 400 mg preservative-free, single use vials- The starting dose is 15 mg/kg, iv infusion, every 3 weeks.

Also known as: Avastin

B

Carboplatin DRUG

Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg\*min/ml, iv infusion, every 3 weeks.

B

Paclitaxel DRUG

Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks

B

AG-013736 (axitinib) DRUG

AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID-

Also known as: axitinib Taxol

A

Eligibility Criteria

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

You may qualify if:

• Advanced non squamous cell, lung cancer
• No prior treatment for lung cancer except prior adjuvant therapy if last dose was \>12 months prior to enrollment

You may not qualify if:

• Prior therapy for advanced lung cancer
• The need for blood-thinners
• Coughing up blood

Sponsors & Collaborators

• Pfizer: lead

Study Sites (44)

Pfizer Investigational Site

Baton Rouge, Louisiana, 70809, United States

Location

Pfizer Investigational Site

Pittsfield, Massachusetts, 01201, United States

Location

Pfizer Investigational Site

Columbus, Mississippi, 39705, United States

Location

Pfizer Investigational Site

Corinth, Mississippi, 38834, United States

Location

Pfizer Investigational Site

New Albany, Mississippi, 38652, United States

Location

Pfizer Investigational Site

Oxford, Mississippi, 38655, United States

Location

Pfizer Investigational Site

Southaven, Mississippi, 38671, United States

Location

Pfizer Investigational Site

Tupelo, Mississippi, 38801, United States

Location

Pfizer Investigational Site

Lincoln, Nebraska, 68510, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44109, United States

Location

Pfizer Investigational Site

Bartlett, Tennessee, 38133, United States

Location

Pfizer Investigational Site

Germantown, Tennessee, 38138, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38119, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38120, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75235, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75246, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75390-8590, United States

Location

Pfizer Investigational Site

Lubbock, Texas, 79410, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78284, United States

Location

Pfizer Investigational Site

Wenatchee, Washington, 98801, United States

Location

Pfizer Investigational Site

Prague, 180 81, Czechia

Location

Pfizer Investigational Site

Tábor, 390 03, Czechia

Location

Pfizer Investigational Site

Ústí nad Labem, 401 13, Czechia

Location

Pfizer Investigational Site

Caen, 14076, France

Location

Pfizer Investigational Site

Paris, 75679, France

Location

Pfizer Investigational Site

Pierre-Bénite, 69495, France

Location

Pfizer Investigational Site

Bydgoszcz, 85-796, Poland

Location

Pfizer Investigational Site

Gdansk, 80-462, Poland

Location

Pfizer Investigational Site

Gdynia, 81-519, Poland

Location

Pfizer Investigational Site

Torun, 87 - 100, Poland

Location

Pfizer Investigational Site

Warsaw, 02-097, Poland

Location

Pfizer Investigational Site

Alicante, Alicante, 03010, Spain

Location

Pfizer Investigational Site

Mataró, Barcelona, 08304, Spain

Location

Pfizer Investigational Site

Sabadell, Barcelona, 08208, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46014, Spain

Location

Pfizer Investigational Site

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Pfizer Investigational Site

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Pfizer Investigational Site

Leeds, Yorkshire, LS9 7TF, United Kingdom

Location

Pfizer Investigational Site

Dundee, DD1 9SY, United Kingdom

Location

Pfizer Investigational Site

London, NW1 2PG, United Kingdom

Location

Pfizer Investigational Site

London, SW3 6JJ, United Kingdom

Location

Pfizer Investigational Site

Surrey, SM2 5PT, United Kingdom

Location

Related Publications (1)

• Twelves C, Chmielowska E, Havel L, Popat S, Swieboda-Sadlej A, Sawrycki P, Bycott P, Ingrosso A, Kim S, Williams JA, Chen C, Olszanski AJ, de Besi P, Schiller JH. Randomised phase II study of axitinib or bevacizumab combined with paclitaxel/carboplatin as first-line therapy for patients with advanced non-small-cell lung cancer. Ann Oncol. 2014 Jan;25(1):132-8. doi: 10.1093/annonc/mdt489.

  PMID: 24356624 DERIVED

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma

Interventions

Bevacizumab; Carboplatin; Paclitaxel; Axitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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: January 3, 2008
• First Posted: January 25, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: October 1, 2012
• Last Updated: November 8, 2013
• Results First Posted: May 22, 2012

Record last verified: 2013-10

Locations

FR (3); ES (4); PL (5); US (22); GB (7); CZ (3)