CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
bevacizumab +2 morebiological
Likely dose
Carboplatin AUC=6 IV on day 1 of each 3-week cycle, pemetrexed 500 mg/m² IV on day 1 of each cycle, and bevacizumab 5 mg/kg IV over 90 minutes on day 1 of each cycleAI-extracted
Key inclusion· 9
  • Histologically or cytologically confirmed non-small cell lung cancer of non-squamous histology
  • Stage IIIB disease with malignant pleural effusion, Stage IV disease, or recurrent disease
  • Age 18 years or older
  • ECOG performance status 0-1
Key exclusion· 15
  • Squamous cell carcinoma histology
  • Known CNS metastases by CT scan or MRI
  • History of hemorrhagic disorders
  • Myocardial infarction within past 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00234052
NCT00234052Phase 2Completed

Phase II Trial of Carboplatin and Pemetrexed Plus Bevacizumab in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

Northwestern University·interventional·Posted Oct 6, 2005·Updated Jun 4, 2019

In Brief

A Phase 2 clinical trial evaluating bevacizumab, carboplatin, and 1 other intervention for Lung Cancer. Completed, enrolled 51 participants across 5 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 6, 2005
Enrollment StartJul 28, 2005
Primary CompletionMar 1, 2011
Study CompletionNov 28, 2011
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 20.7 years ago

Interventions

bevacizumabbiological

5 mg/kg administered intravenously over 90 minutes on day 1 of each cycle (cycle = 3 weeks)

carboplatindrug

Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle (1 cycle = 3 weeks)

pemetrexeddrug

Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle (1 cycle = 3 weeks)