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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Pemetrexed
Radiotherapy
Folic Acid
vitamin B12
carboplatin
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gainsville Hematology Oncology Associates
  • Watson Clinic Center for Cancer Care and Research
  • Wellstar Cancer Research
  • Consultants in Blood Disorders and Cancer
  • Oncology Hematology Care
  • Associates in Hematology Oncology
  • Tennessee Oncology, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Time to Progression

Secondary Outcome Measures

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.
Overall Survival
Overall survival was defined as the interval between the date of study entry until the date of death

Full Information

First Posted
November 21, 2006
Last Updated
November 4, 2021
Sponsor
SCRI Development Innovations, LLC
Collaborators
Genentech, Inc., Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00402883
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to bevacizumab and chemoradiotherapy toxicity
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Genentech, Inc., Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
500mg/m2 week 1, 4, 16, 19 and 22.
Intervention Type
Procedure
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
RT
Intervention Description
1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks)
Intervention Type
Other
Intervention Name(s)
Folic Acid
Intervention Description
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 Type
Other
Intervention Name(s)
vitamin B12
Intervention Description
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 Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
AUC=5 administered intravenously weeks 1 and 4.
Primary Outcome Measure Information:
Title
Time to Progression
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
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.
Time Frame
18 months
Title
Overall Survival
Description
Overall survival was defined as the interval between the date of study entry until the date of death
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Spigel, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gainsville Hematology Oncology Associates
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Watson Clinic Center for Cancer Care and Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Wellstar Cancer Research
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Consultants in Blood Disorders and Cancer
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Associates in Hematology Oncology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19901100
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.
Results Reference
result

Learn more about this trial

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

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