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

• 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.

• Overall Survival [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
• Progression-Free Survival [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
• Duration of Response [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
• Overall Safety Profile [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]

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

• 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

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.