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

NCT00025389 | Completed Phase 2

• 4 other identifiers: 12653AUCCRC-12653ANCI-2655OSU-0120
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate (complete and partial responses by RECIST)

  4 years

Study Arms (1)

Arm A

EXPERIMENTAL

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

Biological: bevacizumab; Drug: carboplatin; Drug: paclitaxel; Procedure: conventional surgery; Procedure: neoadjuvant therapy

Interventions

bevacizumab BIOLOGICAL

Arm A

carboplatin DRUG

Arm A

paclitaxel DRUG

Arm A

conventional surgery PROCEDURE

Arm A

neoadjuvant therapy PROCEDURE

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

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

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Carboplatin; Paclitaxel; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Combined Modality Therapy; Therapeutics

Study Officials

• Ann M. Mauer, MD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: November 1, 2001
• Primary Completion: December 1, 2005
• Study Completion: August 1, 2007
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

US (2)