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

Stopped early · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00960297

Run by

SCRI Development Innovations, LLC

People needed

4

Starts

2009-08-01

Expected to finish

2013-05-01

Last updated by the study team

2021-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Laboratory values as follows:
• Absolute neutrophil count (ANC) >=1500/µL
• Hemoglobin (Hgb) >=9 g/dL
• Platelets >=100,000/uL
• AST/SGOT and ALT/SGPT within normal limits (WNL)
• Total bilirubin within normal limits (WNL)
• Creatinine <=1.5 mg/dL
• ECOG Performance Status grade 0 or 1.
• Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
• Patient must be accessible for treatment and follow-up.

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).
• Patients with a serious non-healing wound, active ulcer, or untreated bone fracture.
• Patients with evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1 of study treatment.
• Women who are pregnant (positive pregnancy test) or lactating.
• Use of any non-approved or investigational agent within 28 days of administration of the first dose of study drug.
• Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
• Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
• History of hypersensitivity to active or inactive excipients of any component of treatment.
• Inability to comply with study and/or follow-up procedures.

Where it is running

• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Providence Medical Group — Terre Haute, Indiana, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Grand Rapids Clinical Oncology Program — Grand Rapids, Michigan, United States
• Portsmouth Regional Hospital — Portsmouth, New Hampshire, United States
• Tennessee Oncology — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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