Clinical trial NCT00735904: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung (NSCLC)
Keywords: AG-013736
axitinib
cisplatin
gemcitabine
NSCLC
squamous cell
lung cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: 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 outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline until death or assessed every 2 months (up to 28 days after the last dose)
measure: Progression Free Survival (PFS)
timeFrame: Baseline, assessed every 2 months (up to 28 days after the last dose)
measure: Duration of Response (DR)
timeFrame: 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)
Other outcomes:
Locations:
city: Torun
country: Poland
facility: Pfizer Investigational Site
city: Wodzislaw Sl.
country: Poland
facility: Pfizer Investigational Site
city: Cluj-Napoca
country: Romania
facility: Pfizer Investigational Site
state: Cluj
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Oradea
country: Romania
facility: Pfizer Investigational Site
city: Parktown
country: South Africa
facility: Pfizer Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Donetsk
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Lviv
country: Ukraine
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.