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Randomized Phase 2 Trial Of AG013736 Or Bevacizumab In Combination With Paclitaxel And Carboplatin As First Line Treatment For Patients With Advanced Non Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small-Cell Lung Carcinoma, Adenocarcinoma

Thank you

Trial Information

Randomized Phase 2 Trial Of AG013736 Or Bevacizumab In Combination With Paclitaxel And Carboplatin As First Line Treatment For Patients With Advanced Non Small Cell Lung Cancer


Inclusion Criteria:



- Advanced non squamous cell, lung cancer

- No prior treatment for lung cancer except prior adjuvant therapy if last dose was
>12 months prior to enrollment

Exclusion Criteria:

- Prior therapy for advanced lung cancer

- The need for blood-thinners

- Coughing up blood

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

Time in months from start of study treatment to first randomization date of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the first randomization 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").

Outcome Time Frame:

Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4061030

NCT ID:

NCT00600821

Start Date:

April 2008

Completion Date:

October 2012

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Pfizer Investigational Site Cincinnait, Ohio  45236
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Shreveport, Louisiana  71103
Pfizer Investigational Site Omaha, Nebraska  68198
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Olive Branch, Mississippi  38654