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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

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