Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer

Part of paid clinical trials in Gainesville, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00402883
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49.
  • Pemetrexed — DRUG
    500mg/m2 week 1, 4, 16, 19 and 22.
  • Radiotherapy — PROCEDURE
    1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks)
  • Folic Acid — OTHER
    350 to 1,000 ug or equivalent supplementation administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinues study therapy.
  • vitamin B12 — OTHER
    1,000ug administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinues therapy.
  • carboplatin — DRUG
    AUC=5 administered intravenously weeks 1 and 4.

Study Details

The purpose of this study is to see if this combination of chemotherapy plus radiation therapy and immunotherapy (with bevacizumab) expands treatment options for patients with non-small cell lung cancer.

Key Dates

First listed
Nov 22, 2006
Start date
Nov 30, 2006
Status verified
Nov 2021
Primary completion
Jan 31, 2009
Completion
Jan 31, 2009

Study Design

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

Arms

  • Experimental: Intervention
    Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.

Primary Outcome Measure

Time to Progression [ Time Frame: 18 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Gainsville Hematology Oncology AssociatesGainesvilleFlorida32605-
Watson Clinic Center for Cancer Care and ResearchLakelandFlorida33805-
Wellstar Cancer ResearchMariettaGeorgia30060-
Consultants in Blood Disorders and CancerLouisvilleKentucky40207-
Oncology Hematology CareCincinnatiOhio45242-
Associates in Hematology OncologyChattanoogaTennessee37404-
Tennessee Oncology, PLLCNashvilleTennessee37023-

Find similar trials in Gainesville, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Gainsville Hematology Oncology Associates· Gainesville, FLWatson Clinic Center for Cancer Care and Research· Lakeland, FLWellstar Cancer Research· Marietta, GAConsultants in Blood Disorders and Cancer· Louisville, KYOncology Hematology Care· Cincinnati, OHAssociates in Hematology Oncology· Chattanooga, TN

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