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

NCT00642759 | Completed Phase 2 Results DMC

• 1 other identifier: 07-339
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; Abraxane; Carboplatin; Bevacizumab; Avastin

Outcome Measures

Primary Outcomes (1)

• 6-month Progression Free Survival Rate

  Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  6 Months

Secondary Outcomes (3)

• Objective Response Rate to Carboplatin, Abraxane and Avastin

  3 years

• 6 Month Survival Rate

  6 months

• Overall Survival

  3 years

Study Arms (1)

Chemotherapy

EXPERIMENTAL

Carboplatin, nab-paclitaxel, and bevacizumab

Drug: carboplatin; Drug: Nab-paclitaxel; Drug: Bevacizumab

Interventions

carboplatin DRUG

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

Chemotherapy

Nab-paclitaxel DRUG

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

Chemotherapy

Bevacizumab DRUG

IV infusion

Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1cm 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
• years of age or older
• Adequate bone marrow, renal and liver function as outlined in the protocol

You may not qualify if:

• 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
• Symptomatic CNS metastases or newly diagnosed CNS metastases that have not yet been definitively treated with radiation and/or surgery. Note that patients with a history of CNS metastases or cord compression are allowed if they have been definitively treated and are clinically stable. Maintenance steroids are allowed. Two weeks need to elapse from the completion of radiation, or 4 weeks from surgery, before starting avastin. Patients do have to remain clinically asymptomatic.
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Celgene Corporation: collaborator
• Genentech, Inc.: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; 130-nm albumin-bound paclitaxel; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Rebecca Heist
• Organization: Massachusetts General Hospital

rheist@partners.org

6177244000

Study Officials

• Rebecca Heist, MD MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2008
• First Posted: March 25, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 7, 2017
• Results First Posted: December 12, 2016

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)