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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00735904
First received: August 13, 2008
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung (NSCLC)
Drug: AG-013736
Drug: gemcitabine
Drug: cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Objective Response (OR) [ 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) ] [ Designated as safety issue: No ]
    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 Frame: Baseline until death or assessed every 2 months (up to 28 days after the last dose) ] [ Designated as safety issue: No ]
    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 Frame: Baseline, assessed every 2 months (up to 28 days after the last dose) ] [ Designated as safety issue: No ]
    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 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 38
Study Start Date: December 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AG-013736/Cisplatin/Gemcitabine Drug: AG-013736
AG-013736 5 mg tablets orally, twice daily, until disease progression
Other Name: axitinib
Drug: gemcitabine
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
Drug: cisplatin
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735904

Locations
Poland
Pfizer Investigational Site
Torun, Poland, 87-100
Pfizer Investigational Site
Wodzislaw Sl., Poland, 44-300
Romania
Pfizer Investigational Site
Cluj-Napoca, Cluj, Romania, 400015
Pfizer Investigational Site
Bucuresti, Romania, 022328
Pfizer Investigational Site
Oradea, Romania, 410032
South Africa
Pfizer Investigational Site
Parktown, South Africa, 2193
Ukraine
Pfizer Investigational Site
Dnipropetrovsk, Ukraine, 49102
Pfizer Investigational Site
Donetsk, Ukraine, 83092
Pfizer Investigational Site
Kyiv, Ukraine, 04107
Pfizer Investigational Site
Lviv, Ukraine, 79031
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00735904     History of Changes
Other Study ID Numbers: A4061038
Study First Received: August 13, 2008
Results First Received: November 30, 2012
Last Updated: November 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
AG-013736
axitinib
cisplatin
gemcitabine
NSCLC
squamous cell
lung cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 24, 2014