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
18 Years
N/A
Both
Carcinoma, Non-Small-Cell Lung (NSCLC)
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Participants With Objective Response (OR)
Outcome 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.
Outcome 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)
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A4061038
NCT ID:
NCT00735904
Start Date:
December 2008
Completion Date:
November 2011
Related Keywords:
- Carcinoma, Non-Small-Cell Lung (NSCLC)
- AG-013736
- axitinib
- cisplatin
- gemcitabine
- NSCLC
- squamous cell
- lung cancer
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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