- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00960297
Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III NSCLC
December 3, 2021 updated by: SCRI Development Innovations, LLC
Phase II Trial of Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III Non-Small Cell Lung Cancer
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Adjuvant chemotherapy for patients with completely resected stage II and select stage III NSCLC is considered standard therapy.
At least three large, prospective randomized trials have proven the benefit of adjuvant chemotherapy in improving survival in these patients (with a magnitude of benefit ranging from 4-12%).
However, in patients who are not considered to be candidates for up-front complete resection, preoperative therapy may be indicated.
Many of these patients will subsequently be eligible for resection (bimodality therapy).
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.
This trial will be conducted by the Sarah Cannon Research Institute Oncology Research Consortium.
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.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Fort Lauderdale, Florida, United States, 33308
- Holy Cross Hospital
-
-
Indiana
-
Terre Haute, Indiana, United States, 47802
- Providence Medical Group
-
-
Kentucky
-
Louisville, Kentucky, United States, 40207
- Norton Cancer Institute
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49503
- Grand Rapids Clinical Oncology Program
-
-
New Hampshire
-
Portsmouth, New Hampshire, United States, 03801
- Portsmouth Regional Hospital
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Tennessee Oncology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Carboplatin/Paclitaxel/Bevacizumab
Preoperative chemotherapy and bevacizumab
|
Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64
Other Names:
Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64
Other Names:
Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 36 months
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 60 months
|
60 months
|
|
Clinical & Pathologic Response Rate
Time Frame: 60 months
|
60 months
|
|
Complete Resection Rate
Time Frame: 60 months
|
60 months
|
|
Number of Participants Experiencing Adverse Events as a Measure of Toxicity
Time Frame: 45 months
|
An adverse event (AE) is the development of an undesirable medical condition, or the deterioration of a preexisting medical condition (other than the condition that is being treated by the trial) following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
The number of participants experiencing such adverse events are reported here.
|
45 months
|
Progression-free Survival
Time Frame: 60 months
|
60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: David R Spigel, M.D., SCRI Development Innovations, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
August 13, 2009
First Submitted That Met QC Criteria
August 14, 2009
First Posted (Estimate)
August 17, 2009
Study Record Updates
Last Update Posted (Actual)
December 6, 2021
Last Update Submitted That Met QC Criteria
December 3, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Carboplatin
- Paclitaxel
- Bevacizumab
Other Study ID Numbers
- SCRI LUN 144
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-Small Cell Lung Cancer
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
Memorial Sloan Kettering Cancer CenterAstraZenecaRecruitingNSCLC | Lung Cancer | Non-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | PD-L1 Gene Mutation | Non-small Cell Lung Cancer Stage IIIA | Non-small Cell Lung Cancer Stage IIUnited States
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)WithdrawnStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on Carboplatin
-
Eisai Inc.CompletedCancerUnited States, Austria, India
-
Samyang Biopharmaceuticals CorporationCompleted
-
NHS Greater Glasgow and ClydeCompletedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity CancerUnited Kingdom, Australia, New Zealand
-
Duke UniversityCompletedBrain and Central Nervous System TumorsUnited States, Canada
-
National Cancer Institute (NCI)CompletedBreast Cancer | Ovarian CancerUnited States
-
National Cancer Institute (NCI)Children's Oncology GroupCompletedBrain and Central Nervous System TumorsUnited States, Canada, Puerto Rico, Australia, Netherlands, New Zealand, Switzerland
-
All India Institute of Medical Sciences, New DelhiCouncil of Scientific and Industrial Research, IndiaUnknownIntraocular RetinoblastomaIndia
-
MEI Pharma, Inc.CompletedPeritoneal Neoplasms | Ovarian Cancer | Fallopian Tube CancerUnited States, Spain, Belgium, United Kingdom, Australia, Italy, Poland
-
Medical Research CouncilEuropean Organisation for Research and Treatment of Cancer - EORTCCompletedTesticular Germ Cell TumorUnited Kingdom, Canada, Norway, Netherlands, South Africa, Brazil, Finland
-
AkesoRecruitingAdvanced Squamous Non Small Cell Lung CancerChina