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Monoclonal Antibodies

Chemotherapy + Radiation + Bevacizumab for Lung Cancer

Phase 2
Waitlist Available
Led By Antoinette J Wozniak
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresectable disease
Histologically or cytologically confirmed single, primary, bronchogenic, non-small cell lung cancer (NSCLC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year
Awards & highlights

Study Summary

This trial is testing a combination of chemotherapy drugs, radiation therapy, and the drug bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer.

Who is the study for?
This trial is for adults with newly diagnosed stage III non-small cell lung cancer that can't be removed by surgery. They should not have had previous treatments for lung cancer, no serious wounds or fractures, and must not be pregnant or nursing. Participants need to meet specific medical criteria like normal kidney function and blood counts, and they cannot have brain metastases or other conditions that pose a high risk of bleeding.Check my eligibility
What is being tested?
The study tests a combination of chemotherapy drugs (cisplatin, etoposide, docetaxel), radiation therapy, and the monoclonal antibody bevacizumab. The goal is to see if this mix can better kill tumor cells by stopping their growth and cutting off their blood supply compared to standard treatments.See study design
What are the potential side effects?
Possible side effects include increased risk of bleeding due to bevacizumab's effect on blood vessels; nerve damage; fatigue from chemotherapy; skin reactions from radiation; as well as potential heart problems like hypertension or congestive heart failure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
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My condition cannot be treated with surgery.
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My lung cancer is confirmed to be non-small cell type.
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It has been over a week since my last biopsy or mediastinoscopy.
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My lung cancer is non-squamous and considered low risk.
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My lung cancer is considered high-risk based on its type and test results.
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My cancer is at stage IIIB with specific conditions.
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I am not currently undergoing intensity-modulated radiotherapy.
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I have 1 or fewer lung lesions.
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I do not have any serious wounds, ulcers, or broken bones that are not healing.
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My condition was recently diagnosed.
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I have not had cancer before, except for certain types.
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I have not had surgery to remove my condition.
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I am not currently receiving any specialized radiation treatments.
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I am not receiving preventive radiation therapy to lymph nodes near my collarbone or opposite lung.
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My lung can handle the planned radiation dose without too much damage.
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I am not receiving any other cancer treatments right now.
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I have not had chemotherapy or radiotherapy for lung cancer.
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My cancer stage fits one of the trial's required stages.
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It's been over 4 weeks since my last major surgery and I have recovered.
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My kidney, lung function, blood counts, and clotting ability are normal.
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My cancer is at stage IIIA with specific N2 lymph node involvement.
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I am not on any full-dose blood thinners.
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I am not undergoing any major surgeries right now.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Secondary outcome measures
Overall Survival
Progression-free Survival
Response Rate (Confirmed or Unconfirmed Partial Response)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3 (cisplatin, etoposide, radiotherapy, bevacizumab)Experimental Treatment7 Interventions
Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 22, and 43.
Group II: Group 2 (cisplatin, etoposide, radiotherapy, bevacizumab)Experimental Treatment7 Interventions
Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 15, 36, and 57.
Group III: Group 1 (cisplatin, etoposide, radiotherapy)Experimental Treatment6 Interventions
Patients receive cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Etoposide
2010
Completed Phase 3
~2440
Bevacizumab
2013
Completed Phase 4
~5280
Docetaxel
1995
Completed Phase 4
~5620
Pegfilgrastim
2013
Completed Phase 3
~4410
Filgrastim
2000
Completed Phase 3
~3670
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,617 Total Patients Enrolled
Antoinette J WozniakPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00334815 β€” Phase 2
Lung Adenocarcinoma Research Study Groups: Group 2 (cisplatin, etoposide, radiotherapy, bevacizumab), Group 3 (cisplatin, etoposide, radiotherapy, bevacizumab), Group 1 (cisplatin, etoposide, radiotherapy)
Lung Adenocarcinoma Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT00334815 β€” Phase 2
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00334815 β€” Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any slots available to join this research endeavor?

"As per the information available on clinicaltrials.gov, this medical study is not actively taking partcipants at present. It was first posted in June 2006 and last updated just over a month ago; however, there are 4,747 other trials still recruiting patients right now."

Answered by AI

How many individuals are partaking in this clinical investigation?

"This medical trial is not presently looking for volunteers. The research, which was first posted on June 15th 2006 and last updated November 16th 2022, has concluded its recruitment period. If you are searching other studies, there currently exists 3126 trials actively seeking participants with lung cancer as well as 1621 clinical trails involving Bevacizumab that are recruiting patients."

Answered by AI

To what extent can Bevacizumab be detrimental to a human's health?

"Bevacizumab's safety has been assessed and found to be satisfactory, hence why it received a rating of 2. This is because the drug is currently being tested in Phase 2 trials with data confirming its security but not yet demonstrating efficacy."

Answered by AI

Is Bevacizumab being tested in other clinical trials?

"In 1997, the City of Hope Comprehensive Cancer Centre was the first to study bevacizumab. As of 2021, there has been a total of 3410 clinical trials completed with 1621 now actively recruiting participants - many based in Olympia Washington."

Answered by AI

How many centers are overseeing this trial?

"Recruitment for this clinical trial is taking place at Providence - Saint Peter Hospital in Olympia, Washington, Hutchinson Regional Medical Center in Hutchinson, Kansas and Audie L Murphy VA Hospital in San Antonio, Texas. Additionally there are 65 other sites across the United States where recruitment is being conducted."

Answered by AI

To what extent does Bevacizumab assist in the treatment of various diseases?

"Bevacizumab is primarily used to target recurrent cervical cancer, but it can also prove effective against metastatic bladder cancer, prostate cancer and other advanced malignancies."

Answered by AI
~2 spots leftby Mar 2025