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Non-Small Cell Lung CancerPhase 2NCT00960297

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

A Phase 2 study testing Carboplatin, Paclitaxel and Bevacizumab in people with Non-Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Carboplatin, Paclitaxel and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
6 sitesUnited States
Study dates
Aug 2009to May 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Portsmouth Regional Hospital

    Portsmouth, New Hampshire, 03801

  • Providence Medical Group

    Terre Haute, Indiana, 47802

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
Non-Small Cell Lung Cancer, NSCLC, Preoperative chemotherapy, Bevacizumab, Avastin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Paraplatin

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

  • PaclitaxelDrug

    Also called Taxol

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

  • BevacizumabDrug

    Also called Avastin

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

Study groups in NCT00960297
Study groupRoleWhat they receive
Carboplatin/Paclitaxel/BevacizumabExperimentalPreoperative chemotherapy and bevacizumab
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 36 months

Secondary outcomes (5)

  1. Clinical & Pathologic Response Rate

    Measured: 60 months

  2. Complete Resection Rate

    Measured: 60 months

  3. Number of Participants Experiencing Adverse Events as a Measure of Toxicity

    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.

    Measured: 45 months

  4. Progression-free Survival

    Measured: 60 months

  5. Overall Survival

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionNov 2012
  4. Study completionMay 2013

Why it stopped: Study was terminated due to slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00960297
Sponsor's protocol ID
SCRI LUN 144
Status last verified
Dec 2021
First submitted
13 Aug 2009
Last updated
6 Dec 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Paclitaxel and Bevacizumab in people with Non-Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00960297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.

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