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Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00735904
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : January 3, 2013
Last Update Posted : January 3, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung (NSCLC)
Interventions Drug: AG-013736
Drug: gemcitabine
Drug: cisplatin
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Axitinib + Cisplatin + Gemcitabine
Hide Arm/Group Description Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
Period Title: Overall Study
Started 38
Completed 0
Not Completed 38
Reason Not Completed
Adverse Event             3
Death             20
Protocol Violation             1
Withdrawal by Subject             1
Study Terminated by Sponsor             5
Other             8
Arm/Group Title Axitinib + Cisplatin + Gemcitabine
Hide Arm/Group Description Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
60.5  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
4
  10.5%
Male
34
  89.5%
1.Primary Outcome
Title Percentage of Participants With Objective Response (OR)
Hide Description Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.
Time Frame Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug.
Arm/Group Title Axitinib + Cisplatin + Gemcitabine
Hide Arm/Group Description:
Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
39.5
(24.0 to 56.6)
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time Frame Baseline until death or assessed every 2 months (up to 28 days after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who received at least 1 dose of study drug.
Arm/Group Title Axitinib + Cisplatin + Gemcitabine
Hide Arm/Group Description:
Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
Overall Number of Participants Analyzed 38
Median (95% Confidence Interval)
Unit of Measure: Months
14.2
(11.8 to 23.1)
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose 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").
Time Frame Baseline, assessed every 2 months (up to 28 days after the last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who received at least 1 dose of study drug.
Arm/Group Title Axitinib + Cisplatin + Gemcitabine
Hide Arm/Group Description:
Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
Overall Number of Participants Analyzed 38
Median (95% Confidence Interval)
Unit of Measure: Months
6.2
(4.5 to 9.3)
4.Secondary Outcome
Title Duration of Response (DR)
Hide Description Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time Frame Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)
Hide Outcome Measure Data
Hide Analysis Population Description
DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response (CR or PR).
Arm/Group Title Axitinib + Cisplatin + Gemcitabine
Hide Arm/Group Description:
Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
Overall Number of Participants Analyzed 15
Median (95% Confidence Interval)
Unit of Measure: Months
5.78
(4.7 to 7.2)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Axitinib + Cisplatin + Gemcitabine
Hide Arm/Group Description Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
All-Cause Mortality
Axitinib + Cisplatin + Gemcitabine
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Axitinib + Cisplatin + Gemcitabine
Affected / at Risk (%)
Total   15/38 (39.47%) 
Blood and lymphatic system disorders   
Anaemia * 1  2/38 (5.26%) 
Neutropenia * 1  1/38 (2.63%) 
Gastrointestinal disorders   
Haematemesis * 1  1/38 (2.63%) 
General disorders   
Disease progression * 1  2/38 (5.26%) 
Fatigue * 1  1/38 (2.63%) 
Multi-organ failure * 1  1/38 (2.63%) 
Infections and infestations   
Lung abscess * 1  1/38 (2.63%) 
Pneumonia * 1  2/38 (5.26%) 
Injury, poisoning and procedural complications   
Femoral neck fracture * 1  1/38 (2.63%) 
Metabolism and nutrition disorders   
Dehydration * 1  2/38 (5.26%) 
Nervous system disorders   
Cerebrovascular accident * 1  1/38 (2.63%) 
Hemiplegia * 1  1/38 (2.63%) 
Ischaemic stroke * 1  1/38 (2.63%) 
Pulmonary artery thrombosis * 1  1/38 (2.63%) 
Pulmonary embolism * 1  1/38 (2.63%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  1/38 (2.63%) 
Haemoptysis * 1  1/38 (2.63%) 
Vascular disorders   
Hypertension * 1  1/38 (2.63%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Axitinib + Cisplatin + Gemcitabine
Affected / at Risk (%)
Total   34/38 (89.47%) 
Blood and lymphatic system disorders   
Anaemia * 1  11/38 (28.95%) 
Leukopenia * 1  5/38 (13.16%) 
Neutropenia * 1  9/38 (23.68%) 
Thrombocytopenia * 1  4/38 (10.53%) 
Gastrointestinal disorders   
Diarrhoea * 1  5/38 (13.16%) 
Nausea * 1  16/38 (42.11%) 
Vomiting * 1  11/38 (28.95%) 
General disorders   
Asthenia * 1  6/38 (15.79%) 
Chest pain * 1  4/38 (10.53%) 
Fatigue * 1  6/38 (15.79%) 
Hyperthermia * 1  2/38 (5.26%) 
Pyrexia * 1  2/38 (5.26%) 
Infections and infestations   
Influenza * 1  2/38 (5.26%) 
Investigations   
Alanine aminotransferase increased * 1  2/38 (5.26%) 
Blood creatinine increased * 1  2/38 (5.26%) 
Creatinine renal clearance decreased * 1  5/38 (13.16%) 
Weight decreased * 1  9/38 (23.68%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  8/38 (21.05%) 
Nervous system disorders   
Hemiparesis * 1  2/38 (5.26%) 
Peripheral sensory neuropathy * 1  2/38 (5.26%) 
Renal and urinary disorders   
Nephropathy toxic * 1  4/38 (10.53%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  4/38 (10.53%) 
Dyspnoea * 1  3/38 (7.89%) 
Haemoptysis * 1  2/38 (5.26%) 
Pulmonary cavitation * 1  3/38 (7.89%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  5/38 (13.16%) 
Rash * 1  4/38 (10.53%) 
Vascular disorders   
Hypertension * 1  10/38 (26.32%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00735904    
Other Study ID Numbers: A4061038
First Submitted: August 13, 2008
First Posted: August 15, 2008
Results First Submitted: November 30, 2012
Results First Posted: January 3, 2013
Last Update Posted: January 3, 2013