Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III NSCLC

NCT00960297 | Terminated Phase 2 Results

• 1 other identifier: SCRI LUN 144
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 6

Brief Summary

The rationale for this multicenter, phase II trial is to examine the impact of carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage IB (\> 4.0 cm), II, and select stage III NSCLC. If this novel regimen proves to be safe and active in this setting, this would provide rationale for further investigation in a larger, prospective, randomized setting.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; NSCLC; Preoperative chemotherapy; Bevacizumab; Avastin

Outcome Measures

Primary Outcomes (1)

• To Assess 3-year Overall Survival in Patients With Stage IB (>4.0 cm), II, or Select Stage III NSCLC Treated With Preoperative Carboplatin, Paclitaxel, and Bevacizumab Followed by Surgical Resection.

  36 months

Secondary Outcomes (5)

• Clinical & Pathologic Response Rate

  60 months

• Complete Resection Rate

  60 months

• Number of Participants Experiencing Adverse Events as a Measure of Toxicity

  45 months

• Progression-free Survival

  60 months

• Overall Survival

  60 months

Study Arms (1)

Carboplatin/Paclitaxel/Bevacizumab

EXPERIMENTAL

Preoperative chemotherapy and bevacizumab

Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab

Interventions

Carboplatin DRUG

Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64

Also known as: Paraplatin

Carboplatin/Paclitaxel/Bevacizumab

Paclitaxel DRUG

Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64

Also known as: Taxol

Carboplatin/Paclitaxel/Bevacizumab

Bevacizumab DRUG

Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)

Also known as: Avastin

Carboplatin/Paclitaxel/Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Age \>=18 years.
• Histologically-confirmed NSCLC (adenocarcinoma, large cell, and undifferentiated). Patients with squamous histology are not eligible.
• Life expectancy of at least 12 weeks.
• Patients with the following stages of NSCLC:
• T2 N0 tumors: Limited to tumors \>=4 cm.
• T1-2 N1 tumors.
• T3 N0-1 tumors (excluding superior sulcus tumors): Including tumors involving the chest wall, proximal airway, or mediastinal pleura where preoperative RT is not planned.
• T1-2 N2 tumors: For patients with N2 disease involving 1 zone (Upper zone (R), AP zone (L), subcarinal zone, or lower zone) and nodes \<=2 cm in diameter.
• T4 N0-1 tumors (excluding superior sulcus tumors): T4 lesions, other than malignant effusions where radiotherapy is not planned.
• Patients with clinical N2 involvement must have histologic confirmation by mediastinoscopy (or alternate biopsy procedure).
• Tumors should be considered potentially resectable.
• No evidence of extrathoracic metastatic disease.
• Patients must have measurable disease by RECIST version 1.1 criteria.
• Patients must be candidates (medically) for chemotherapy followed by surgical resection.
• Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery (with the exception of portacath or other central access catheter placement); at least 4 weeks must have elapsed from the time of a major surgery.

You may not qualify if:

• Mixed small-cell and non-small cell histologies.
• Pulmonary carcinoid tumors.
• History of prior malignancy within 3 years, with the exception of non-melanoma skin cancer or carcinoma in situ.
• Peripheral neuropathy \>= grade 1.
• Patients receiving thrombolytic therapy within 10 days of starting study treatment are ineligible. Therapeutic anticoagulation is allowed if the anticoagulant dosing is stable.
• History of acute myocardial infarction or unstable angina within 6 months prior to Day 1 of study treatment.
• History of or stroke or ischemic attack within 6 months prior to Day 1 of study treatment.
• Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) in spite of medical management.
• New York Heart Association (NYHA) class II or greater congestive heart failure (CHF).
• Patients with significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of study treatment.
• Any prior history of hypertensive crisis or hypertensive encephalopathy.
• Patients with hematemesis or hemoptysis (\>=1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1 of study treatment.
• Proteinuria at screening, as demonstrated by either:
• Urine protein: creatinine (UPC) ratio \>=1.0 (see Appendix A) at screening, or
• Urine dipstick for proteinuria \>=2+ (patients discovered to have \>=2+ proteinuria on dipstick analysis should undergo a 24-hour urine collection and must have \<=1g of protein in 24 hours to be eligible).

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Genentech, Inc.: collaborator

Study Sites (6)

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Portsmouth Regional Hospital

Portsmouth, New Hampshire, 03801, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Paclitaxel; Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: David R. Spigel, M.D.
• Organization: Study Chair

David.Spigel@scresearch.net

1-877-MY-1-SCRI

Study Officials

• David R Spigel, M.D.

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: August 13, 2009
• First Posted: August 17, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: December 6, 2021
• Results First Posted: November 8, 2013

Record last verified: 2021-12

Locations

US (6)