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

Primary Purpose

Carcinoma, Non-Small-Cell Lung (NSCLC)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AG-013736
gemcitabine
cisplatin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung (NSCLC) focused on measuring AG-013736, axitinib, cisplatin, gemcitabine, NSCLC, squamous cell, lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically- or cytologically-confirmed diagnosis of squamous NSCLC Stage IIIB with malignant effusion (fluid cytology demonstrating malignant cells required), Stage IV, or recurrent disease after definitive local therapy
  • Candidate for primary treatment with cisplatin and gemcitabine
  • Presence of measurable disease by RECIST
  • Adequate organ function as defined by the following criteria: ECOG performance status of 0 or 1

Exclusion Criteria:

  • Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC.
  • One or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by CT or MRI.
  • History of hemoptysis > ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment
  • NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment
  • Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
  • Untreated brain metastases.
  • Need for therapeutic anticoagulation, regular use of aspirin (> 325 mg/day), NSAID or other medications known to inhibit platelet function.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AG-013736/Cisplatin/Gemcitabine

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Objective Response (OR)
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.

Secondary Outcome Measures

Overall Survival (OS)
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).
Progression Free Survival (PFS)
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").
Duration of Response (DR)
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.

Full Information

First Posted
August 13, 2008
Last Updated
November 30, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00735904
Brief Title
Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer
Official Title
Phase 2 Trial Of AG-013736 As First-Line Treatment For Patients With Squamous Non-Small Cell Lung Cancer Receiving Treatment With Cisplatin And Gemcitabine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung (NSCLC)
Keywords
AG-013736, axitinib, cisplatin, gemcitabine, NSCLC, squamous cell, lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AG-013736/Cisplatin/Gemcitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AG-013736
Other Intervention Name(s)
axitinib
Intervention Description
AG-013736 5 mg tablets orally, twice daily, until disease progression
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
200-mg or 1 g lyophilized powder, to be administered as 1250 mg/m^2 IV infusion on Day 1 and Day 8 of 21-day cycle. For a maximum of 6 cycles
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
1mg/ml solution or as lyophilized powder, to be administered as 80 mg/m^2 IV infusion on Day 1 of 21-day cycle. For a maximum of 6 cycles
Primary Outcome Measure Information:
Title
Percentage of Participants With Objective Response (OR)
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)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
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)
Title
Progression Free Survival (PFS)
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)
Title
Duration of Response (DR)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically- or cytologically-confirmed diagnosis of squamous NSCLC Stage IIIB with malignant effusion (fluid cytology demonstrating malignant cells required), Stage IV, or recurrent disease after definitive local therapy Candidate for primary treatment with cisplatin and gemcitabine Presence of measurable disease by RECIST Adequate organ function as defined by the following criteria: ECOG performance status of 0 or 1 Exclusion Criteria: Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC. One or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by CT or MRI. History of hemoptysis > ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. Untreated brain metastases. Need for therapeutic anticoagulation, regular use of aspirin (> 325 mg/day), NSAID or other medications known to inhibit platelet function.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Pfizer Investigational Site
City
Wodzislaw Sl.
ZIP/Postal Code
44-300
Country
Poland
Facility Name
Pfizer Investigational Site
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Pfizer Investigational Site
City
Oradea
ZIP/Postal Code
410032
Country
Romania
Facility Name
Pfizer Investigational Site
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
25929582
Citation
Bondarenko IM, Ingrosso A, Bycott P, Kim S, Cebotaru CL. Phase II study of axitinib with doublet chemotherapy in patients with advanced squamous non-small-cell lung cancer. BMC Cancer. 2015 May 1;15:339. doi: 10.1186/s12885-015-1350-6.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4061038&StudyName=Trial%20Of%20AG-013736%2C%20Cisplatin%2C%20And%20Gemcitabine%20For%20Patients%20With%20Squamous%20Non-Small%20Cell%20Lung%20Cancer
Description
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Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer

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