Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

A Phase II Study of Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00402883
• Other study ID #: SCRI LUN 134
• Status: Terminated
• Phase: Phase 2
• Start date: November 2006
• Est. completion date: January 2009

Study information

• Verified date: November 2021
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Bevacizumab
15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49.
• Pemetrexed
500mg/m2 week 1, 4, 16, 19 and 22.

Procedure:
• Radiotherapy
1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks)

Other:
• Folic Acid
350 to 1,000 ug or equivalent supplementation administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinues study therapy.
• vitamin B12
1,000ug administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinues therapy.

Drug:
• carboplatin
AUC=5 administered intravenously weeks 1 and 4.

Locations

Country	Name	City	State
United States	Associates in Hematology Oncology	Chattanooga	Tennessee
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Gainsville Hematology Oncology Associates	Gainesville	Florida
United States	Watson Clinic Center for Cancer Care and Research	Lakeland	Florida
United States	Consultants in Blood Disorders and Cancer	Louisville	Kentucky
United States	Wellstar Cancer Research	Marietta	Georgia
United States	Tennessee Oncology, PLLC	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Eli Lilly and Company, Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression		18 months
Secondary	Objective Response Rate	The objective benefit is defined as substantial shrinkage in tumor volume per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and is assessed by MRI or CT. Objective response = complete response + partial response. Complete Response (CR) is defined as the Disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions.	18 months
Secondary	Overall Survival	Overall survival was defined as the interval between the date of study entry until the date of death	18 months

External Links

•   Published article in the Journal of Clinical Oncology