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Radiation Therapy, Chemotherapy, and Bevacizumab in Treating Patients With Recurrent, Unresectable or Stage III or Stage IV Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
carboplatin
chemoprotection
paclitaxel
radiation therapy
Sponsored by
Northwestern University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, squamous cell lung cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Predominantly squamous cell histology Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy Advanced disease, meeting 1 of the following staging criteria: Stage IIIB disease with malignant pleural effusion Stage IV disease Recurrent, unresectable disease Measurable or nonmeasurable disease No extrathoracic only disease No known CNS metastases by head CT scan with contrast or MRI PATIENT CHARACTERISTICS: ECOG performance status 0-1 Platelet count > 100,000/mm^3 Absolute neutrophil count > 1,500/mm^3 Bilirubin < 1.5 mg/dL Transaminases < 5 times upper limit of normal (ULN) Creatinine clearance ≥ 45 mL/min Urine protein:creatinine ratio ≤ 1.0 by spot urinalysis INR < 1.5 ULN PTT normal Not pregnant or nursing Negative pregnancy test Fertile patients use effective contraception No serious nonhealing wound, ulcer, or bone fracture No ongoing or active infection No ongoing fever No myocardial infarction within the past 6 months No stroke within the past 6 months No history of hypertension unless well-controlled (i.e., blood pressure < 150/100 mmHg on a stable regimen of antihypertensive therapy) No New York Heart Association grade III or IV congestive heart failure No serious cardiac arrhythmia requiring medication No unstable angina pectoris No peripheral vascular disease ≥ grade 2 No other clinically significant cardiovascular disease No abdominal fistula No gastrointestinal perforation No intra-abdominal abscess within the past 6 months No psychiatric illness or social situation that would preclude study compliance No other malignancy curatively treated within the past 5 years No history of thrombotic or hemorrhagic disorders No gross hemoptysis (i.e., red blood ≥ ½ teaspoon) within the past 3 months No bleeding requiring intervention or ≥ grade 2 PRIOR CONCURRENT THERAPY: Recovered from prior therapy No prior systemic chemotherapy for metastatic NSCLC More than 6 months since prior adjuvant chemotherapy for early stage (i.e., stage IB-IIIA) NSCLC More than 3 weeks since prior immunotherapy, hormonal therapy, or radiotherapy More than 28 days since prior and no concurrent major surgery More than 7 days since prior minor surgery, fine-needle aspiration, or core biopsy More than 4 weeks since prior and no concurrent participation in another experimental drug study No concurrent therapeutic anticoagulation Concurrent prophylactic anticoagulation of venous access device allowed No concurrent chronic treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function No concurrent dipyridamole, ticlopidine, clopidogrel, or cilostazol

Sites / Locations

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Evanston Northwestern Healthcare - Evanston Hospital
  • Vanderbilt-Ingram Cancer Center
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Outcomes

Primary Outcome Measures

Reduction in toxicity measured by pulmonary hemorrhage rate

Secondary Outcome Measures

Overall survival by Kaplan-Meier
Response rate
Toxicity

Full Information

First Posted
June 7, 2006
Last Updated
July 9, 2012
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00334763
Brief Title
Radiation Therapy, Chemotherapy, and Bevacizumab in Treating Patients With Recurrent, Unresectable or Stage III or Stage IV Non-Small Cell Lung Cancer
Official Title
Phase II Study of Radiation Followed by Paclitaxel, Carboplatin, and Bevacizumab (PCA) in Patients With Stage IIIB and IV Squamous Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator felt risk to patients was too high.
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving radiation therapy together with chemotherapy and monoclonal antibody therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving radiation therapy together with chemotherapy and bevacizumab works in treating patients with recurrent, unresectable or stage III or stage IV non-small cell lung cancer.
Detailed Description
OBJECTIVES: Primary Evaluate reduction in toxicity, in terms of pulmonary hemorrhage, in patients with recurrent, unresectable or stage IIIB or IV squamous non-small cell lung cancer treated with radiotherapy followed by paclitaxel, carboplatin, and bevacizumab. Secondary Determine the overall and progression-free survival of patients treated with this regimen. OUTLINE: Patients undergo radiotherapy to the primary tumor, clinically involved lymph nodes, and any other disease-causing symptoms or bronchial compression once daily, 5 days a week, for 2 weeks in weeks 1 and 2. Beginning in week 4, patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel, carboplatin, and bevacizumab repeats every 3 weeks for 4 courses in the absence of unacceptable toxicity. Patients achieving complete response, partial response, or stable disease after 4 courses receive bevacizumab alone as above in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months. PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, squamous cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
chemoprotection
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Reduction in toxicity measured by pulmonary hemorrhage rate
Secondary Outcome Measure Information:
Title
Overall survival by Kaplan-Meier
Title
Response rate
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Predominantly squamous cell histology Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy Advanced disease, meeting 1 of the following staging criteria: Stage IIIB disease with malignant pleural effusion Stage IV disease Recurrent, unresectable disease Measurable or nonmeasurable disease No extrathoracic only disease No known CNS metastases by head CT scan with contrast or MRI PATIENT CHARACTERISTICS: ECOG performance status 0-1 Platelet count > 100,000/mm^3 Absolute neutrophil count > 1,500/mm^3 Bilirubin < 1.5 mg/dL Transaminases < 5 times upper limit of normal (ULN) Creatinine clearance ≥ 45 mL/min Urine protein:creatinine ratio ≤ 1.0 by spot urinalysis INR < 1.5 ULN PTT normal Not pregnant or nursing Negative pregnancy test Fertile patients use effective contraception No serious nonhealing wound, ulcer, or bone fracture No ongoing or active infection No ongoing fever No myocardial infarction within the past 6 months No stroke within the past 6 months No history of hypertension unless well-controlled (i.e., blood pressure < 150/100 mmHg on a stable regimen of antihypertensive therapy) No New York Heart Association grade III or IV congestive heart failure No serious cardiac arrhythmia requiring medication No unstable angina pectoris No peripheral vascular disease ≥ grade 2 No other clinically significant cardiovascular disease No abdominal fistula No gastrointestinal perforation No intra-abdominal abscess within the past 6 months No psychiatric illness or social situation that would preclude study compliance No other malignancy curatively treated within the past 5 years No history of thrombotic or hemorrhagic disorders No gross hemoptysis (i.e., red blood ≥ ½ teaspoon) within the past 3 months No bleeding requiring intervention or ≥ grade 2 PRIOR CONCURRENT THERAPY: Recovered from prior therapy No prior systemic chemotherapy for metastatic NSCLC More than 6 months since prior adjuvant chemotherapy for early stage (i.e., stage IB-IIIA) NSCLC More than 3 weeks since prior immunotherapy, hormonal therapy, or radiotherapy More than 28 days since prior and no concurrent major surgery More than 7 days since prior minor surgery, fine-needle aspiration, or core biopsy More than 4 weeks since prior and no concurrent participation in another experimental drug study No concurrent therapeutic anticoagulation Concurrent prophylactic anticoagulation of venous access device allowed No concurrent chronic treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function No concurrent dipyridamole, ticlopidine, clopidogrel, or cilostazol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyoti D. Patel
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Evanston Northwestern Healthcare - Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-1781
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Radiation Therapy, Chemotherapy, and Bevacizumab in Treating Patients With Recurrent, Unresectable or Stage III or Stage IV Non-Small Cell Lung Cancer

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