Carboplatin, Abraxane, and Bevacizumab in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Dana-Farber Cancer Institute Abraxis BioScience Inc. Genentech
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00642759

Purpose

The purpose of this research study is to learn more about whether the combination of drugs carboplatin, Abraxane and Avastin helps treat non-small cell lung cancer (NSCLC). One of the standard treatments for advanced NSCLC is the combination of the drugs carboplatin, paclitaxel and Avastin. Paclitaxel can be associated with severe side effects that may make the treatment difficult to tolerate. Some of these side effects are caused by the solution used to dissolve paclitaxel before it can be administered. Abraxane is a different form of paclitaxel that does not need to be dissolved by this solution. Abraxane is approved for the treatment of breast cancer but is not approved to treat NSCLC. We will also be trying to learn more about how the drug Avastin may work to treat cancer.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: carboplatin Drug: Abraxane Drug: Avastin	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial of Carboplatin, Abraxane, and Bevacizumab in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

To determine the 6-month progression free survival rate in the study population. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the safety and tolerability of carboplatin, Abraxane, and Avastin in the study population. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
To determine the objective response rate to carboplatin, Abraxane and Avastin in the study population. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To determine the overall survival in the study population. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	April 2008
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles

Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles

Given by infusion 2 weeks before starting combination chemotherapy and then given on Day 1 of each three week cycle for a total of 6 cycles. Then given alone once every three weeks.

Detailed Description:

Participants will receive a single dose of Avastin 2 weeks before they are scheduled to start the combination of carboplatin, Abraxane and Avastin. Before the dose of Avastin is given, a perfusion CT scan and blood work will be performed. The perfusion CT scan and blood draw will be repeated 12 days after teh Avastin dose (2 days before beginning study treatment).
The combination of carboplatin, Abraxane and Avastin will be given in 3 week cycles and all drugs will be given as infusions. On day 1, Avastin, Abraxane and carboplatin wil be given. On Day 8 and 15, Abraxane will be given.

Participants can receive up to 6 cycles of carboplatin, Abraxane and Avastin if their disease does not get worse and they do not experience intolerable side effects.

The following assessment procedures will be performed on day 1 of each cycle: physical exam; routine urine test (every other cycle); Performance status assessment. Routine blood tests will be performed on days 1, 8 and 15.
Additional procedures performed after cycles 2 and 4 and at 6 months after beginning study treatment are as follows: CT scan, PET scan, perfusion CT and blood work.
After 6 cycles of carboplatin, Abraxane and Avastin, participants will receive Avastin alone for three weeks. Participants can continue to receive Avastin as long as they do not experience unacceptable side effects.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of non-small cell lung carcinoma of non-squamous histology
AJCC stage IIIB or Stage IV
Measurable disease by RECIST criteria, and must have at least one target lesion 2cm or greater in diameter for optimal perfusion CT scanning
No prior chemotherapy treatment or VEGF inhibitor treatment, although prior treatment with EGFR inhibitors will be allowed
18 years of age or older
Adequate bone marrow, renal and liver function as outlined in the protocol

Exclusion Criteria:

Life expectancy of less than 12 weeks
Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
Inadequately controlled hypertension
Any prior history of hypertensive crisis or hypertensive encephalopathy
NYHA Grade II or greater congestive heart failure
History of myocardial infarction or unstable angina within 6 months prior to study enrollment
History of stroke, transient ischemic attack within 6 months prior to study enrollment
Known brain metastases, including previously treated metastases
Significant vascular disease
Symptomatic peripheral vascular disease
Evidence of bleeding diathesis or coagulopathy
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major medical surgical procedure during the course of the study
Minor surgical procedure, excluding FNA, core biopsy or placement of a vascular access device, within 7 days prior to study enrollment
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
Serious, non-healing wound, ulcer, or bone fracture
Proteinuria at screening
Pregnant or lactating
Lung carcinoma of squamous cell histology
History of hemoptysis within 3 months prior to study enrollment
Current, on-going treatment with full-dose warfarin or its equivalent at the onset of treatment
Current or recent (within 10 days of enrollment) use of aspirin or chronic use of other NSAIDs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642759

Contacts

Contact: Rebecca Heist, MD MPH	617-724-4000	rheist@partners.org
Contact: Patricia Ostler, RN	617-724-7829	postler@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Rebecca Heist, MD MPH
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Leena Gandhi, MD, PhD

Sponsors and Collaborators

Massachusetts General Hospital

Dana-Farber Cancer Institute

Abraxis BioScience Inc.

Genentech

Investigators

Principal Investigator:

Rebecca Heist, MD MPH

Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital ( Rebecca Heist, MD MPH )
Study ID Numbers:	07-339, ABX203-LC07US, AVF4298s
Study First Received:	March 21, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00642759
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

NSCLC
Abraxane
Carboplatin
Bevacizumab
Avastin

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases

Carboplatin
Bevacizumab
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009