A Study of Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer

April 28, 2011 updated by: Hoosier Cancer Research Network

Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer (SCLC): A Safety, Feasibility and Efficacy Study

Improvements in therapy for relapsed SCLC are much needed. Paclitaxel has been previously tested and found to have significant single agent activity in relapsed SCLC, including in refractory patients. Angiogenesis plays an important role in SCLC, increased VEGF levels are associated with worse outcomes. Bevacizumab, a monoclonal antibody to VEGF, increase response rates and survival when combined with chemotherapy agents compared with the chemotherapy agent alone in NSCLC, breast cancer, and colorectal cancer. Paclitaxel plus bevacizumab, in the dose and schedule proposed in this study, improves response rates and progression free survival compared with paclitaxel alone in women with metastatic breast cancer. Therefore, we will be testing the safety, feasibility, and efficacy of this regimen in patients with chemosensitive relapsed SCLC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

OUTLINE: This is a multi-center study.

Paclitaxel 90 mg/m2 IV infusion over 1 hour days 1, 8 and 15 of 28 day cycle

Plus

Bevacizumab 10 mg/kg on days 1 and 15 of 28 day cycle.

  • 1 cycle = 28 days (4 weeks)
  • Disease assessments will be performed per RECIST every other cycle
  • After a minimum of 4 cycles or a maximum of 6 cycles of combination chemotherapy, bevacizumab monotherapy may continue until disease progression or intolerable side effects

ECOG Performance Status 0 or 1

Hematopoietic:

  • White blood cell count > 3,000 mm3
  • Absolute neutrophil count (ANC) > 1,500 mm3
  • Platelet count > 100,000 mm3
  • International normalized ration (INR) of prothrombin time ≤ 1.2
  • PTT no more than 5 seconds longer than the ULN

Hepatic:

  • Bilirubin < 1.5 x ULN
  • Aspartate aminotransferase (AST, SGOT) < 2.5 x ULN

Renal:

  • Urine protein:creatinine ratio <1.0

Cardiovascular:

  • No history of myocardial infarction or angina pectoris/anginal equivalent in the last 6 months. Note: The patient may be on anti-anginal medications if the symptoms have been entirely controlled for greater than 6 months.
  • No history of uncontrolled congestive heart failure or uncontrolled hypertension

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Highlands Oncology Group
    • Illinois
      • Galesburg, Illinois, United States, 61401
        • Medical & Surgical Specialists, LLC
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Cancer Care Center of Southern Indiana
      • Evansville, Indiana, United States, 47714
        • Oncology Hematology Associates of SW Indiana
      • Fort Wayne, Indiana, United States, 46815
        • Fort Wayne Oncology & Hematology, Inc
      • Goshen, Indiana, United States, 46527
        • Center for Cancer Care at Goshen Health System
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Quality Cancer Center (MCGOP)
      • Indianapolis, Indiana, United States, 46256
        • Community Regional Cancer Center
      • Lafayette, Indiana, United States, 47904
        • Arnett Cancer Care
      • Muncie, Indiana, United States, 47303
        • Medical Consultants, P.C.
      • New Albany, Indiana, United States, 47150
        • Center for Cancer Care, Inc., P.C.
      • South Bend, Indiana, United States, 46601
        • Northern Indiana Cancer Research Consortium
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Siteman Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Pennsylvania Oncology-Hematology Associates
      • Rockledge, Pennsylvania, United States, 19046
        • Fox Chase Cancer Center Extramural Research Program

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologic or cytologic proof of small cell lung cancer
  • Chemo-sensitive disease defined as relapsed after 60 days from completion of first line chemotherapy.
  • Measurable disease according to RECIST and obtained by imaging within 28 days prior to being registered for protocol therapy.
  • Must have received treatment with at least 1 but not more than 2 prior chemotherapy regimens. (At least one regimen must contain a platinum agent. Previous treatment with irinotecan is allowed.)
  • Prior radiation therapy must be completed at least 21 days prior to being registered for protocol therapy, and toxicities due to radiation must have recovered to ≤ grade 1 or baseline prior to registration.
  • Prior cancer treatment must be completed at least 21 days prior to being registered for protocol therapy and the subject must have recovered from the acute toxicity effects of the regimen prior to registration.

Exclusion Criteria:

  • No treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
  • No history or radiographic evidence of CNS involvement by head CT or MRI within 42 days prior to registration.
  • No history of seizures, transient ischemic attack or stroke.
  • No clinically significant infections as judged by the treating investigator.
  • No other active cancer except SCLC.
  • No prior treatment with topoisomerase I inhibitor.
  • No contraindications to the use of paclitaxel or bevacizumab as per the investigator's clinical judgment.
  • Must not have grade 3 or greater peripheral neuropathy.
  • Must not have had major surgical procedure, open biopsy, or significant traumatic injury within 28 days of being registered for protocol therapy.
  • No anticipation of need for major surgical procedure during the course of the study.
  • Patients may not have had a minor surgical procedure, placement of an access device or fine needle aspiration within 7 days prior to being registered for protocol therapy.
  • No evidence of bleeding diathesis or coagulopathy.
  • No history of deep vein thrombosis or pulmonary embolism.
  • No full dose/therapeutic anticoagulation with either low molecular weight heparin or unfractionated heparin or coumadin within 10 days prior to registration.
  • Patients must not have been using aspirin (>325 mg/day) or another nonsteroidal anti-inflammatory medications known to inhibit platelet function on a daily basis within 10 days prior to registration on study.
  • Patients must not be using any of the following drugs known to inhibit platelet function within 10 days prior to registration: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal).
  • Patients must not have a current non-healing wound or fracture.
  • Patients must not have a history of or current hemoptysis.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1
Paclitaxel + Devacizumab in patients with chemosensitive relapsed small cell lung cancer.
Drug: Paclitaxel
Paclitaxel 90 mg/m2 IV infusion over 1 hour, days 1, 8 and 15 of 28 day cycle.
Drug: Bevacizumab
Bevacizumab 10 mg/kg, days 1 and 15 of 28 day cycle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To determine progression free survival(PFS) of this regimen in patients with chemosensitive relapsed small cell lung cancer (SCLC).
Time Frame: 18 months
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To determine the response rate of the combination of paclitaxel and bevacizumab with chemosensitive SCLC.
Time Frame: 18 months
18 months
To determine the toxicity of the combination of paclitaxel and bevacizumab in patients with SCLC.
Time Frame: 18 months
18 months
To determine overall survival.
Time Frame: 18 months
18 months
To assess VEGF polymorphisms in the study population.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoosier Cancer Research Network

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Genentech, Inc.
Walther Cancer Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Nasser Hanna, M.D., Hoosier Oncology Group, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HOG LUN05-99

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.

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