Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer	Drug: bevacizumab; Drug: carboplatin; Drug: gemcitabine	Phase 2

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Enrollment :	45 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer
Study Start Date :	November 2004

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. time to progression

Secondary Outcome Measures :

1. response rate
2. median survival
3. one year survival
4. two year survival
5. toxicity

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Michael J Kraut, MD	248-849-3541	mkraut@providence-hospital.org
Contact: Jaswinder Grewal, PhD	248-849-5337	jgrewal@providence-hospital.org

Locations

United States, Michigan
Providence Cancer Institute	Recruiting
Southfield, Michigan, United States, 48075
Contact: Michael J Kraut, MD 248-849-8155 mkraut@providence-hospital.org
Contact: Howard Terebelo, DO 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

Sponsors and Collaborators

St. John Providence Health System

Genentech, Inc.

Eli Lilly and Company

Investigators

Principal Investigator:	Michael J Kraut, MD	Providence Cancer Institute

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00150657 History of Changes
Other Study ID Numbers:	AVF3121s
First Posted:	September 8, 2005
Last Update Posted:	November 29, 2005
Last Verified:	September 2005

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Gemcitabine; Bevacizumab; Carboplatin; Antimetabolites, Antineoplastic	Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors