Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Gemcitabine

Axitinib

Cisplatin

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

AG-013736 5 mg tablets orally, twice daily, until disease progression

AG-013736

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

gemcitabine

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

cisplatin

Pfizer CT.gov Call Center

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

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

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

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 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 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 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.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m\^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m\^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.

Axitinib + Cisplatin + Gemcitabine

Age Continuous

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug.

Percentage of Participants With Objective Response (OR)

ITT population included all enrolled participants who received at least 1 dose of study drug.

Overall Survival (OS)

Progression Free Survival (PFS)

DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response (CR or PR).

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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