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Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
carboplatin
paclitaxel
conventional surgery
neoadjuvant therapy
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small 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 Stage IB (T2, N0), II (T1 or T2, N1 or T3, N0), or IIIA (T3, N1) Potentially resectable disease No large central primary tumors in proximity to significant blood vessels No bronchoscopically evident endobronchial tumors At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 OR Karnofsky 70-100% Life expectancy: More than 12 months Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No history of an inherited bleeding disorder No inherited predisposition to a hypercoagulable state No clinically evident hypercoagulable state or bleeding diathesis Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN INR less than 1.5 PTT less than 36 seconds Renal: Creatinine less than 1.5 times ULN OR Creatinine clearance at least 60 mL/min No nephrotic syndrome Urine protein no greater than 0.5 g/24 hours Cardiovascular: No poorly controlled hypertension (greater than 150 mm Hg systolic and/or greater than 100 mm Hg diastolic) despite treatment No uncompensated coronary artery disease No myocardial infarction within the past 6 months No clinically significant or severe peripheral vascular disease No inherited predisposition to thrombosis No deep venous or arterial thrombosis No symptomatic congestive heart failure No unstable angina pectoris within the past 6 months No cardiac arrhythmia No transient ischemic attack within the past 6 months No cerebrovascular accident within the past 6 months No other arterial thromboembolic event within the past 6 months Pulmonary: No hemoptysis No pulmonary embolism Other: No history of allergic reactions to compounds of similar chemical or biologic composition to study drugs No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No psychiatric illness or social situation that would preclude study compliance No significant traumatic injury within the past 28 days No uncontrolled concurrent illness No ongoing or active infection No serious, non-healing wound, ulcer, or bone fracture No other active malignancy No requirement for full-dose anticoagulation or thrombolytic therapy PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for this cancer No concurrent prophylactic growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF]) Chemotherapy: No prior chemotherapy for this cancer Prior chemotherapy for another malignancy allowed provided the prior malignancy was curatively treated and is currently controlled Endocrine therapy: No prior endocrine therapy for this cancer Radiotherapy: No prior radiotherapy for this cancer Prior radiotherapy for another malignancy allowed provided the prior malignancy was curatively treated and is currently controlled No concurrent radiotherapy Surgery: Prior diagnostic bronchoscopy, mediastinoscopy, or CT-guided biopsy allowed At least 28 days since prior major surgical procedure or open biopsy Other: No other concurrent investigational agents No other concurrent anticancer investigational or commercial agents or therapies No concurrent combination antiretroviral therapy for HIV-positive patients Concurrent low-dose warfarin for maintenence of preexisting, permanent, indwelling IV catheters allowed provided INR less than 1.5

Sites / Locations

  • University of Chicago Cancer Research Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

Bevacizumab (15mg/kg, q3wk x 2), Paclitaxel (200 mg/m2, q3wk x 2), carboplatin (AUC of 6, q3wk x 2), followed by surgery 4 to 6 weeks after last dose of Bevacizumab

Outcomes

Primary Outcome Measures

Response Rate (complete and partial responses by RECIST)

Secondary Outcome Measures

Full Information

First Posted
October 11, 2001
Last Updated
February 8, 2013
Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00025389
Brief Title
Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
Official Title
A Phase 2 Study Of Neoadjuvant rhuMAb VEGF (Bevacizumab) In Combination With Paclitaxel And Carboplatin In Surgically Resectable Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy before surgery may may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is to see if bevacizumab, paclitaxel, and carboplatin given before surgery work in treating patients who have stage IB, stage II, or stage IIIA non-small cell lung cancer.
Detailed Description
OBJECTIVES: Determine the clinical complete and partial response rate in patients with stage IB, II, or IIIA resectable non-small cell lung cancer treated with neoadjuvant bevacizumab, paclitaxel, and carboplatin. Determine the pathologic complete response rate in patients treated with this regimen. Determine the ability to proceed with and complete a potentially curative resection in patients treated with this regimen. Determine the safety and toxicity of this regimen in these patients. OUTLINE: Patients receive neoadjuvant bevacizumab IV over 60-90 minutes, paclitaxel IV over 3 hours, and carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo surgical resection within 4-6 weeks after completion of chemotherapy. Patients are followed within 3 months. PROJECTED ACCRUAL: A total of 23-39 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
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell 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
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Bevacizumab (15mg/kg, q3wk x 2), Paclitaxel (200 mg/m2, q3wk x 2), carboplatin (AUC of 6, q3wk x 2), followed by surgery 4 to 6 weeks after last dose of Bevacizumab
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Primary Outcome Measure Information:
Title
Response Rate (complete and partial responses by RECIST)
Time Frame
4 years

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 Stage IB (T2, N0), II (T1 or T2, N1 or T3, N0), or IIIA (T3, N1) Potentially resectable disease No large central primary tumors in proximity to significant blood vessels No bronchoscopically evident endobronchial tumors At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 OR Karnofsky 70-100% Life expectancy: More than 12 months Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No history of an inherited bleeding disorder No inherited predisposition to a hypercoagulable state No clinically evident hypercoagulable state or bleeding diathesis Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN INR less than 1.5 PTT less than 36 seconds Renal: Creatinine less than 1.5 times ULN OR Creatinine clearance at least 60 mL/min No nephrotic syndrome Urine protein no greater than 0.5 g/24 hours Cardiovascular: No poorly controlled hypertension (greater than 150 mm Hg systolic and/or greater than 100 mm Hg diastolic) despite treatment No uncompensated coronary artery disease No myocardial infarction within the past 6 months No clinically significant or severe peripheral vascular disease No inherited predisposition to thrombosis No deep venous or arterial thrombosis No symptomatic congestive heart failure No unstable angina pectoris within the past 6 months No cardiac arrhythmia No transient ischemic attack within the past 6 months No cerebrovascular accident within the past 6 months No other arterial thromboembolic event within the past 6 months Pulmonary: No hemoptysis No pulmonary embolism Other: No history of allergic reactions to compounds of similar chemical or biologic composition to study drugs No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No psychiatric illness or social situation that would preclude study compliance No significant traumatic injury within the past 28 days No uncontrolled concurrent illness No ongoing or active infection No serious, non-healing wound, ulcer, or bone fracture No other active malignancy No requirement for full-dose anticoagulation or thrombolytic therapy PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for this cancer No concurrent prophylactic growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF]) Chemotherapy: No prior chemotherapy for this cancer Prior chemotherapy for another malignancy allowed provided the prior malignancy was curatively treated and is currently controlled Endocrine therapy: No prior endocrine therapy for this cancer Radiotherapy: No prior radiotherapy for this cancer Prior radiotherapy for another malignancy allowed provided the prior malignancy was curatively treated and is currently controlled No concurrent radiotherapy Surgery: Prior diagnostic bronchoscopy, mediastinoscopy, or CT-guided biopsy allowed At least 28 days since prior major surgical procedure or open biopsy Other: No other concurrent investigational agents No other concurrent anticancer investigational or commercial agents or therapies No concurrent combination antiretroviral therapy for HIV-positive patients Concurrent low-dose warfarin for maintenence of preexisting, permanent, indwelling IV catheters allowed provided INR less than 1.5
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann M. Mauer, MD
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer

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