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

NCT00402883 | Terminated Phase 2 Results

• 1 other identifier: SCRI LUN 134
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 7

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  18 months

Secondary Outcomes (2)

• Objective Response Rate

  18 months

• Overall Survival

  18 months

Study Arms (1)

Intervention

EXPERIMENTAL

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; Drug: Pemetrexed; Procedure: Radiotherapy; Other: Folic Acid; Other: vitamin B12; Drug: carboplatin

Interventions

Bevacizumab DRUG

15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49.

Also known as: Avastin

Intervention

Pemetrexed DRUG

500mg/m2 week 1, 4, 16, 19 and 22.

Also known as: Alimta

Intervention

Radiotherapy PROCEDURE

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

Also known as: RT

Intervention

Folic Acid OTHER

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.

Intervention

vitamin B12 OTHER

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.

Intervention

carboplatin DRUG

AUC=5 administered intravenously weeks 1 and 4.

Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Genentech, Inc.: collaborator
• Eli Lilly and Company: collaborator

Study Sites (7)

Gainsville Hematology Oncology Associates

Gainesville, Florida, 32605, United States

Location

Watson Clinic Center for Cancer Care and Research

Lakeland, Florida, 33805, United States

Location

Wellstar Cancer Research

Marietta, Georgia, 30060, United States

Location

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, 40207, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

Associates in Hematology Oncology

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

Related 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: 10.1200/JCO.2009.24.7353. Epub 2009 Nov 9.

  PMID: 19901100 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bevacizumab; Pemetrexed; Radiotherapy; Folic Acid; Vitamin B 12; Carboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Therapeutics; Pterins; Pteridines; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: John Hainsworth, MD
• Organization: Sarah Cannon Research Institute

asksarah@scresearch.net

1-877-691-7274

Study Officials

• David Spigel, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2006
• First Posted: November 22, 2006
• Study Start: November 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: November 9, 2021
• Results First Posted: January 13, 2014

Record last verified: 2021-11

Locations

US (7)