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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

34

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

  • 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

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
Intervention / Treatment
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

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

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

Hoosier Cancer Research Network

Collaborators

Genentech, Inc.
Walther Cancer Institute

Investigators

  • 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

April 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

April 20, 2006

First Submitted That Met QC Criteria

April 20, 2006

First Posted (Estimate)

April 24, 2006

Study Record Updates

Last Update Posted (Estimate)

May 2, 2011

Last Update Submitted That Met QC Criteria

April 28, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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