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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

This study is currently recruiting patients.

Sponsored by

Arthur G. James, Cancer Hospital & Richard J. Solove, Research Institute

National Cancer Institute (NCI)

Purpose

RATIONALE: Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy before surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of bevacizumab, paclitaxel, and carboplatin given before surgery in treating patients who have stage IB, stage II, or stage IIIA non-small cell lung cancer.

MEDLINEplus related topics:  Cancer (General);   Cancer Alternative Therapy;   Cancer--Living with Cancer;   Lung Cancer;   Respiratory Diseases (General)

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Neoadjuvant Bevacizumab, Paclitaxel, and Carboplatin in Patients With Stage IB, II, or IIIA Resectable Non-Small Cell Lung Cancer

Further Study Details: 

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.

Eligibility

Ages Eligible for Study: 18 Years  and above

Genders Eligible for Study: Both

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 no greater than 1.5
     PTT no greater 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 history of myocardial infarction
     No severe peripheral vascular disease
     No inherited predisposition to thrombosis
     No deep venous or arterial thrombosis
     No symptomatic congestive heart failure
     No unstable angina pectoris
     No cardiac arrhythmia

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

Location and Contact Information

Ohio
     Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting.
     Gregory Otterson, MD  614-293-3121 

Study chairs or principal investigators:
     Gregory Otterson, MD,  Study Chair,  Arthur G. James Cancer Hospital & Richard J. Solove Research Institute   

More Information
     Study ID Numbers CDR0000068956;  OSU-NCI-2655; NCI-2655
     Record last reviewed  February 2003
     NLM Identifier  NCT00025389

ClinicalTrials.gov processed this record on 2003-05-30

Source: Clinicaltrials.gov