Clinical trial NCT00402883: Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
Official title: A Phase II Study of Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Eli Lilly and Company
First posted: 2006-11-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if this combination of chemotherapy plus radiation therapy and immunotherapy (with bevacizumab) expands treatment options for patients with non-small cell lung cancer.

Detailed description: The patients on this study will receive treatment in 3 stages of therapy.

The first stage is Induction Therapy. This therapy is 7 weeks long. Patients will receive bevacizumab followed by pemetrexed followed by carboplatin all by vein once a week in weeks 1 and 4. During Induction patients will also receive radiation therapy daily, Monday through Friday, for 7 weeks (weeks 1-7). This is followed by 2 weeks of rest. During this rest period patients will have scans done to see how their disease has responded to treatment.

The next stage of treatment is Consolidation Therapy. This stage is 10 weeks long. Patients will receive bevacizumab followed by pemetrexed followed by carboplatin all by vein once a week in weeks 10, 13 and 16. This is followed by 3 weeks rest. During week 19 patients will have scans to see how their disease has responded to treatment.

The last stage of treatment is Maintenance Therapy. Patients will receive bevacizumab alone by vein every 3 weeks. Treatment will be given every three weeks for up to 9 treatments. (week 45)

Eligibility criteria: Inclusion Criteria:

* Clinically confirmed non-small cell lung cancer stage IIIA and selected stage IIIB
* Measurable or evaluable disease
* Be up and about and able to care for self
* Adequate kidney, liver and bone marrow function
* No prior treatment for this disease
* Must be able to give written informed consent
* Must be able to take folic acid, vitamin B12 and dexamethasone as described in the protocol
* Age 18 years or older

Exclusion Criteria:

* Stage IV or IIIB patients with pleural or pericardial effusions
* Stage IIIB disease with contralateral mediastinal nodes greater than 4cm
* Squamous cell predominant tumors
* Pregnant or lactating women
* Patients with active infections
* History of another cancer within the last 5 years with the exception of skin cancer or cervical carcinoma in situ
* History of stroke, transient ischemic attacks, or acute MI within the past 6 months or any other serious cardiovascular disease
* Symptoms of peripheral vascular disease
* History of neurological disease
* Recent history of blood in the sputum or vomitus
* Non-healing wounds, ulcer or long bone fractures
* History of bleeding problems or coagulation problems
* History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 6 months
* History of uncontrolled hypertension
* Chronic use of non-steroidal anti-inflammatory medication not allowed on this study

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Primary outcomes:
measure: Time to Progression
timeFrame: 18 months
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 18 months
measure: Overall Survival
timeFrame: 18 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Gainsville Hematology Oncology Associates
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Cancer Care and Research
state: Florida
city: Marietta
country: United States
facility: Wellstar Cancer Research
state: Georgia
city: Louisville
country: United States
facility: Consultants in Blood Disorders and Cancer
state: Kentucky
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Chattanooga
country: United States
facility: Associates in Hematology Oncology
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: David Spigel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spigel DR, Hainsworth JD, Yardley DA, Raefsky E, Patton J, Peacock N, Farley C, Burris HA 3rd, Greco FA. Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol. 2010 Jan 1;28(1):43-8. doi: 10.1200/JCO.2009.24.7353. Epub 2009 Nov 9.