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

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung (NSCLC)
• Interventions: Drug: AG-013736; Drug: gemcitabine; Drug: cisplatin

• Registration Number: NCT00735904
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-15
• Study Start: 2008-12
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Disposition First Submitted: 2011-12-16
• Disposition First Submitted QC: 2011-12-16
• Disposition First Posted: 2011-12-22
• Status Verified: 2012-11
• Results First Submitted: 2012-11-30
• Results First Submitted QC: 2012-11-30
• Last Update Submitted: 2012-11-30
• Results First Posted: 2013-01-03
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AG-013736/Cisplatin/Gemcitabine	AG-013736	-
AG-013736/Cisplatin/Gemcitabine	gemcitabine	-
AG-013736/Cisplatin/Gemcitabine	cisplatin	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Objective Response (OR)	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)	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

Name	Time	Method
Duration of Response (DR)	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)	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 (OS)	Baseline until death or assessed every 2 months (up to 28 days after the last dose)	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)	Baseline, assessed every 2 months (up to 28 days after the last dose)	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").

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇦 Lviv, Ukraine