A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00600821

First received: January 3, 2008

Last updated: November 8, 2012

Last verified: November 2012

History of Changes

Results First Received: April 20, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Non-Small-Cell Lung Carcinoma Adenocarcinoma
Interventions:	Drug: Bevacizumab Drug: Carboplatin Drug: Paclitaxel Drug: AG-013736 (axitinib)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Axitinib + Paclitaxel + Carboplatin	Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily (BID) along with infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin area under the concentration-time curve (AUC) of 6 mgminute/milliliter (mgmin/mL) infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
Bevacizumab + Paclitaxel + Carboplatin	Bevacizumab 15 mg/kilogram (mg/kg) infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.

Description

Axitinib + Paclitaxel + Carboplatin

Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily (BID) along with infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin area under the concentration-time curve (AUC) of 6 mg*minute/milliliter (mg*min/mL) infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.

Bevacizumab + Paclitaxel + Carboplatin

Bevacizumab 15 mg/kilogram (mg/kg) infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.

Participant Flow: Overall Study

	Axitinib + Paclitaxel + Carboplatin	Bevacizumab + Paclitaxel + Carboplatin
STARTED	58	60
Treated	58	59
COMPLETED	0	0
NOT COMPLETED	58	60
Death	44	46
Lost to Follow-up	2	2
Withdrawal by Subject	1	1
Terminated by sponsor	8	6
Ongoing	1	3
Objective progression or relapse	0	1
Randomized but not treated	0	1
Unspecified	2	0

Baseline Characteristics

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Reporting Groups

	Description
Axitinib + Paclitaxel + Carboplatin	Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
Bevacizumab + Paclitaxel + Carboplatin	Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
Total	Total of all reporting groups

Baseline Measures

	Axitinib + Paclitaxel + Carboplatin	Bevacizumab + Paclitaxel + Carboplatin	Total
Number of Participants [units: participants]	58	60	118
Age, Customized [units: Participants]
Less than 18 years	0	0	0
18 to 44 years	1	2	3
45 to 64 years	33	44	77
Greater than or equal to 65 years	24	14	38
Gender [units: Participants]
Female	22	23	45
Male	36	37	73

Outcome Measures

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1. Primary:

Progression Free Survival (PFS) [ Time Frame: Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years ]

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2. Secondary:

Overall Survival (OS) [ Time Frame: Baseline, every 6 weeks until death or bimonthly after final study visit (up to 2.75 years) ]

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3. Secondary:

Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years ]

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4. Secondary:

Duration of Response (DR) [ Time Frame: Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years ]

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5. Secondary:

European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score [ Time Frame: Day (D) 1 of every cycle (C) then every 3 weeks until final study visit (up to 2.75 years) ]

Show Outcome Measure 5

6. Secondary:

European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score [ Time Frame: Day 1 of every cycle then every 3 weeks until final study visit (up to 2.75 years) ]

Show Outcome Measure 6

7. Secondary:

Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile in Whole Blood [ Time Frame: Baseline, C1 D1, C1 D15, C2 D1, C3 D1, C4 D1 and C5 D1 ]

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8. Secondary:

Circulating Endothelial Cells (CEC) in Blood: Total CEC [ Time Frame: Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1 ]

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9. Secondary:

Circulating Endothelial Cells (CEC) in Blood [ Time Frame: Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1 ]

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10. Secondary:

Plasma Concentration of Soluble Proteins [ Time Frame: Baseline, C1D1, C1D15, C2D1, C3D1, C4D1, C5D1, C7D1, C9D1 and C11D1 ]

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11. Other Pre-specified:

Plasma Concentration Change in the Uridine Diphosphate Glucuronosyltransferase 1A1 (UGT1A1) Genotype [ Time Frame: Baseline (Day 1 of Cycle 1) ]

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Measure Type	Other Pre-specified
Measure Title	Plasma Concentration Change in the Uridine Diphosphate Glucuronosyltransferase 1A1 (UGT1A1) Genotype
Measure Description	UGT1A1 an enzyme of the glucuronidation pathway that transforms small lipophilic molecules, such as steroids, bilirubin, hormones, and drugs, into water-soluble, excretable metabolites.
Time Frame	Baseline (Day 1 of Cycle 1)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data was reported in listings but not summarized due to statistical constraints.

Reporting Groups

	Description
Axitinib + Paclitaxel + Carboplatin	Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive Axitinib (AG-013736) BID maintenance therapy.
Bevacizumab+ Paclitaxel + Carboplatin	Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive Axitinib (AG-013736) BID maintenance therapy.

Measured Values

	Axitinib + Paclitaxel + Carboplatin	Bevacizumab+ Paclitaxel + Carboplatin
Number of Participants Analyzed [units: participants]	0	0
Plasma Concentration Change in the Uridine Diphosphate Glucuronosyltransferase 1A1 (UGT1A1) Genotype

No statistical analysis provided for Plasma Concentration Change in the Uridine Diphosphate Glucuronosyltransferase 1A1 (UGT1A1) Genotype

12. Secondary:

Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736) [ Time Frame: Pre-dose, 1 to 2 hours post-dose on Cycle 2 of Day 1 and Cycle 3 of Day 1 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00600821 History of Changes
Other Study ID Numbers:	A4061030
Study First Received:	January 3, 2008
Results First Received:	April 20, 2012
Last Updated:	November 8, 2012
Health Authority:	United States: Food and Drug Administration

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