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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Drug: Bevacizumab; Drug: Pemetrexed; Procedure: Radiotherapy; Other: Folic Acid; Other: vitamin B12; Drug: carboplatin	Phase 2

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)

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	5 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Study of Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
Study Start Date :	November 2006
Actual Primary Completion Date :	January 2009
Actual Study Completion Date :	January 2009

Arms and Interventions

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Arm

Intervention/treatment

Experimental: Intervention; Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.

Drug: Bevacizumab; 15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49.; Other Name: Avastin Drug: Pemetrexed; 500mg/m2 week 1, 4, 16, 19 and 22.; Other Name: Alimta Procedure: Radiotherapy; 1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks); Other Name: RT 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. Other: 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.

Outcome Measures

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Primary Outcome Measures :

1. Time to Progression [ Time Frame: 18 months ]

Secondary Outcome Measures :

1. To Evaluate the Objective Response Rates [ Time Frame: 18 months ]
2. Overall Survival [ Time Frame: 18 months ]

Eligibility Criteria

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

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.

Contacts and Locations

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Locations

United States, Florida
Gainsville Hematology Oncology Associates
Gainesville, Florida, United States, 32605
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States, 33805
United States, Georgia
Wellstar Cancer Research
Marietta, Georgia, United States, 30060
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Associates in Hematology Oncology
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023

Sponsors and Collaborators

SCRI Development Innovations, LLC

Genentech, Inc.

Eli Lilly and Company

Investigators

Principal Investigator:	David Spigel, MD	SCRI Development Innovations, LLC

More Information

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

Additional Information:

Published article in the Journal of Clinical Oncology 

Publications of Results:

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.

Responsible Party:	SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:	NCT00402883 History of Changes
Other Study ID Numbers:	SCRI LUN 134
First Posted:	November 22, 2006
Results First Posted:	January 13, 2014
Last Update Posted:	January 13, 2014
Last Verified:	November 2013

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; Vitamins; Folic Acid; Vitamin B 12; Hydroxocobalamin; Bevacizumab	Carboplatin; Pemetrexed; Vitamin B Complex; Micronutrients; Growth Substances; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Inhibitors; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Hematinics