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Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer

Primary Purpose

Non-Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
carboplatin
gemcitabine
Sponsored by
St. John Providence Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically or cytologically proven non-small cell lung cancer, newly diagnosed or recurrent after previous surgery and/or radiation therapy Stage IV disease or stage IIIB with a malignant pleural effusion measurable or evaluable disease Performance status 0 or 1 (ECOG) adequate renal, hepatic, and bone marrow function adequate recovery from previous surgery or radiotherapy informed consent Exclusion Criteria: brain metastases squamous (epidermoid) histology hemoptysis central airway disease Pancoast tumors previous chemotherapy or biologic therapy for lung cancer prior malignancy within the previous 5 years except non-melanoma skin cancer or cervical CIS pregnant or nursing women

Sites / Locations

  • Providence Cancer InstituteRecruiting

Outcomes

Primary Outcome Measures

time to progression

Secondary Outcome Measures

response rate
median survival
one year survival
two year survival
toxicity

Full Information

First Posted
September 6, 2005
Last Updated
November 28, 2005
Sponsor
St. John Providence Health System
Collaborators
Genentech, Inc., Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00150657
Brief Title
Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer
Official Title
Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
St. John Providence Health System
Collaborators
Genentech, Inc., Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
this study is being done to find out if the combination of carboplatin and gemcitabine will be more effective in the the treatment of advanced lung cancer if bevacizumab, an agent that blocks tumor blood vessel formation, is added the study will measure the time to progression of patients treated with the combination; we hope to show that the addition of bevacizumab improves the time to progression (increases the amount of time before the disease begins to worsen) all patients receive all three drugs; there is no placebo
Detailed Description
Patients with advanced (stage IV, and Stage IIIB with effusion) non-small cell lung cancer with non-squamous histology, good performance status, and adequate organ function are eligible. Patients with brain metastases, squamous histology, or hemoptysis are excluded. All patients must give informed consent. Schema gemcitabine 1250 mg/M2 IV day 1,8 carboplatin AUC 5 IV day 1 bevacizumab 15 mg/kg IV day 1 repeated every 21 days for 6 cycles

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Primary Outcome Measure Information:
Title
time to progression
Secondary Outcome Measure Information:
Title
response rate
Title
median survival
Title
one year survival
Title
two year survival
Title
toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically proven non-small cell lung cancer, newly diagnosed or recurrent after previous surgery and/or radiation therapy Stage IV disease or stage IIIB with a malignant pleural effusion measurable or evaluable disease Performance status 0 or 1 (ECOG) adequate renal, hepatic, and bone marrow function adequate recovery from previous surgery or radiotherapy informed consent Exclusion Criteria: brain metastases squamous (epidermoid) histology hemoptysis central airway disease Pancoast tumors previous chemotherapy or biologic therapy for lung cancer prior malignancy within the previous 5 years except non-melanoma skin cancer or cervical CIS pregnant or nursing women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael J Kraut, MD
Phone
248-849-3541
Email
mkraut@providence-hospital.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jaswinder Grewal, PhD
Phone
248-849-5337
Email
jgrewal@providence-hospital.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Kraut, MD
Organizational Affiliation
Providence Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Cancer Institute
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J Kraut, MD
Phone
248-849-8155
Email
mkraut@providence-hospital.org
First Name & Middle Initial & Last Name & Degree
Howard Terebelo, DO
Phone
248-552-0620
First Name & Middle Initial & Last Name & Degree
Michael J Kraut, MD
First Name & Middle Initial & Last Name & Degree
Howard Terebelo, DO
First Name & Middle Initial & Last Name & Degree
Anibal Drelichman, MD
First Name & Middle Initial & Last Name & Degree
Robert Bloom, MD
First Name & Middle Initial & Last Name & Degree
Lyle Goldman, MD
First Name & Middle Initial & Last Name & Degree
Judie Goodman, DO

12. IPD Sharing Statement

Learn more about this trial

Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer

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