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

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Pfizer
Study ID
NCT00600821
Phase
PHASE2
Status
Completed

Conditions

  • Adenocarcinoma
  • Non-Small-Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab is available as 100 and 400 mg preservative-free, single use vials- The starting dose is 15 mg/kg, iv infusion, every 3 weeks.
  • Carboplatin — DRUG
    Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg\*min/ml, iv infusion, every 3 weeks.
  • Paclitaxel — DRUG
    Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks
  • AG-013736 (axitinib) — DRUG
    AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID-
  • Carboplatin — DRUG
    Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg\*min/ml, iv infusion, every 3 weeks.
  • Paclitaxel — DRUG
    Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks

Study Details

To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated.

Key Dates

First listed
Jan 25, 2008
Start date
Apr 30, 2008
Status verified
Oct 2013
Primary completion
Apr 30, 2011
Completion
Oct 31, 2012

Study Design

Enrollment
118 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: B
    Bevacizumab will be administered in combination with carboplatin and paclitaxel.
  • Experimental: A
    AG-013736 will be administered in combination with carboplatin and paclitaxel.

Primary Outcome Measure

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

Locations (22)

FacilityCityStateZIPSite coordinators
Pfizer Investigational SiteBaton RougeLouisiana70809-
Pfizer Investigational SitePittsfieldMassachusetts01201-
Pfizer Investigational SiteColumbusMississippi39705-
Pfizer Investigational SiteCorinthMississippi38834-
Pfizer Investigational SiteNew AlbanyMississippi38652-
Pfizer Investigational SiteOxfordMississippi38655-
Pfizer Investigational SiteSouthavenMississippi38671-
Pfizer Investigational SiteTupeloMississippi38801-
Pfizer Investigational SiteLincolnNebraska68510-
Pfizer Investigational SiteClevelandOhio44109-
Pfizer Investigational SiteBartlettTennessee38133-
Pfizer Investigational SiteGermantownTennessee38138-
Pfizer Investigational SiteMemphisTennessee38119-
Pfizer Investigational SiteMemphisTennessee38120-
Pfizer Investigational SiteDallasTexas75230-
Pfizer Investigational SiteDallasTexas75235-
Pfizer Investigational SiteDallasTexas75246-
Pfizer Investigational SiteDallasTexas75390-8590-
Pfizer Investigational SiteLubbockTexas79410-
Pfizer Investigational SiteSan AntonioTexas78229-
Pfizer Investigational SiteSan AntonioTexas78284-
Pfizer Investigational SiteWenatcheeWashington98801-

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Pfizer Investigational Site· Baton Rouge, LAPfizer Investigational Site· Pittsfield, MAPfizer Investigational Site· Columbus, MSPfizer Investigational Site· Corinth, MSPfizer Investigational Site· New Albany, MSPfizer Investigational Site· Oxford, MS

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