Phase 2 Trial of Bevacizumab in Combination With Pemetrexed

Part of paid clinical trials in Stanford, California.

Sponsor
Heather Wakelee
Study ID
NCT00227019
Phase
PHASE2
Status
Completed

Conditions

  • Lung Cancer
  • Neoplasm Metastasis
  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    15 mg/kg, IV over 10 minutes every 3 weeks
  • Pemetrexed — DRUG
    500 mg/m²; IV over 10 minutes every 3 weeks
  • Vitamin B12 — DRUG
    1000 micrograms, IM injection 1-2 weeks prior to treatment and repeated every 9 weeks until last dose of pemetrexed
  • Folate — DRUG
    350 to 1000 micrograms 1 week prior to treatment and 3 weeks after last pemetrexed dose
  • Dexamethasone — DRUG
    4 mg; oral, twice a day at the following times: the day before, of and after each dose of pemetrexed

Study Details

This trial evaluated the safety of combining bevacizumab and pemetrexed in non-small cell lung cancer (NSCLC) patients with stable brain metastases as second-line chemotherapy, while evaluating progression-free survival (PFS) and overall survival (OS).

Key Dates

First listed
Sep 27, 2005
Start date
Mar 31, 2006
Status verified
Jan 2017
Primary completion
Nov 30, 2010
Completion
Dec 31, 2016

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: bevacizumab+ pemetrexed
    pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV). In addition to Vitamin B12 + Folate + Dexamethasone

Primary Outcome Measure

Incidence of Central Nervous System (CNS) Hemorrhagic Events [ Time Frame: 18 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-
Norris Cotton Cancer CenterLebanonNew Hampshire03756-
Cooper Cancer InstituteVoorhees TownshipNew Jersey08043-
University of North CarolinaChapel HillNorth Carolina27599-

Find similar trials in Stanford, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Stanford University School of Medicine· Stanford, CANorris Cotton Cancer Center· Lebanon, NHCooper Cancer Institute· Voorhees Township, NJUniversity of North Carolina· Chapel Hill, NC

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