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

November 4, 2021 updated by: SCRI Development Innovations, LLC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Avastin
Drug: Pemetrexed
500mg/m2 week 1, 4, 16, 19 and 22.
Other Names:
  • Alimta
Procedure: Radiotherapy
1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks)
Other Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Progression
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 18 months
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
Overall Survival
Time Frame: 18 months
Overall survival was defined as the interval between the date of study entry until the date of death
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCRI Development Innovations, LLC

Collaborators

Eli Lilly and Company
Genentech, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

November 21, 2006

First Submitted That Met QC Criteria

November 21, 2006

First Posted (ESTIMATE)

November 22, 2006

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCRI LUN 134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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