- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00150657
Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer
November 28, 2005 updated by: St. John Providence Health System
Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer
- 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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael J Kraut, MD
- Phone Number: 248-849-3541
- Email: mkraut@providence-hospital.org
Study Contact Backup
- Name: Jaswinder Grewal, PhD
- Phone Number: 248-849-5337
- Email: jgrewal@providence-hospital.org
Study Locations
-
-
Michigan
-
Southfield, Michigan, United States, 48075
- Recruiting
- Providence Cancer Institute
-
Contact:
- Michael J Kraut, MD
- Phone Number: 248-849-8155
- Email: mkraut@providence-hospital.org
-
Contact:
- Howard Terebelo, DO
- Phone Number: 248-552-0620
-
Principal Investigator:
- Michael J Kraut, MD
-
Sub-Investigator:
- Howard Terebelo, DO
-
Sub-Investigator:
- Anibal Drelichman, MD
-
Sub-Investigator:
- Robert Bloom, MD
-
Sub-Investigator:
- Lyle Goldman, MD
-
Sub-Investigator:
- Judie Goodman, DO
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
time to progression
|
Secondary Outcome Measures
Outcome Measure |
---|
response rate
|
toxicity
|
median survival
|
one year survival
|
two year survival
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michael J Kraut, MD, Providence Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Study Registration Dates
First Submitted
September 6, 2005
First Submitted That Met QC Criteria
September 6, 2005
First Posted (Estimate)
September 8, 2005
Study Record Updates
Last Update Posted (Estimate)
November 29, 2005
Last Update Submitted That Met QC Criteria
November 28, 2005
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Gemcitabine
- Carboplatin
- Bevacizumab
Other Study ID Numbers
- AVF3121s
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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