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

NCT ID: NCT00025389

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30
• Study Completion Date: 2007-08-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

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

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: BIOLOGICAL

carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

Interventions

bevacizumab

Intervention Type: BIOLOGICAL

carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann M. Mauer, MD

Role: STUDY_CHAIR

University of Chicago

Locations

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

UCCRC-12653A

Identifier Type: -

Identifier Source: secondary_id

NCI-2655

Identifier Type: -

Identifier Source: secondary_id

OSU-0120

Identifier Type: -

Identifier Source: secondary_id

12653A

Identifier Type: -

Identifier Source: org_study_id