Phase I/II Study to Evaluate the Efficacy and Safety of a Combination Chemotherapy

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT00424840
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Bortezomib 1.3 mg/m2 — DRUG
    Level I (every 21 day cycle, D8), 1.3 mg/m2: Day 1: bevacizumab 15 mg/kg ,carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.3 mg/m2 Day 8 : bortezomib 1.3 mg/m2 Level II (every 21 day cycle): Day 1: bevacizumab 15 mg/kg, carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.6 mg/m2 Day 8 : bortezomib 1.6 mg/m2 Level III(every 21 day cycle): Day 1: bevacizumab 15 mg/kg, carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.8 mg/m2 Day 8 : bortezomib 1.8 mg/m2
  • Bortezomib 1.6 mg/m2 — DRUG
    Level II (every 21 day cycle, D8), 1.6 mg/m2
  • Bortezomib 1.8 mg/m2 — DRUG
    Level III (every 21 day cycle, D8) 1.8 mg/m2
  • Carboplatin AUC 6 — DRUG
    Carboplatin AUC6
  • Bevacizumab — DRUG
    Bevacizumab 15 mg/kg
  • Taxotere — DRUG
    Taxotere 70 + G-CSF

Study Details

A pilot trial of combination of bortezomib, bevacizumab and carboplatin as first line therapy in patients with metastatic Non-Small Cell Lung Cancer (NSCLC). Phase I and II study of this combination in first line setting will be conducted in order to properly estimate the efficacy and safety of this regimen. This will form the basis for future studies comparing this combination to what is now considered standard regimen for first line therapy in patients with NSCLC, carboplatin, paclitaxel and bevacizumab.

Key Dates

First listed
Jan 22, 2007
Start date
Jun 30, 2006
Status verified
Jan 2019
Primary completion
Mar 31, 2014
Completion
Mar 31, 2014

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bortezomib 1.3 mg/m2
    Level 1 of Bortezomib Dose Escalation in combination with Carboplatin AUC6, Bevacizumab 15 mg/kg and Taxotere 70 + G-CSF
  • Experimental: Bortezomib 1.6 mg/m2
    Level 2 of Bortezomib Dose Escalation in combination with Carboplatin AUC6, Bevacizumab 15 mg/kg and Taxotere 70 + G-CSF
  • Experimental: Bortezomib 1.8 mg/m2
    Level 3 of Bortezomib Dose Escalation in combination with Carboplatin AUC6, Bevacizumab 15 mg/kg and Taxotere 70 + G-CSF

Primary Outcome Measure

Number of Subjects Who Require Dose Delay/Reduction in Dose of Bortezomibin the First Cycle [ Time Frame: up to 21 days for each dosing cycle ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Massachusetts Medical SchoolWorcesterMassachusetts01655-0002-

Find similar trials in Worcester, MA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Massachusetts Medical School· Worcester, MA

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