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

This study has been completed.
Sponsor:
Collaborators:
Genentech
Walther Cancer Institute
Information provided by:
Hoosier Oncology Group
ClinicalTrials.gov Identifier:
NCT00317200
First received: April 20, 2006
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer
Drug: Paclitaxel
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer (SCLC): A Safety, Feasibility and Efficacy Study

Resource links provided by NLM:


Further study details as provided by Hoosier Oncology Group:

Primary Outcome Measures:
  • To determine progression free survival(PFS) of this regimen in patients with chemosensitive relapsed small cell lung cancer (SCLC). [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the response rate of the combination of paclitaxel and bevacizumab with chemosensitive SCLC. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To determine the toxicity of the combination of paclitaxel and bevacizumab in patients with SCLC. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • To determine overall survival. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To assess VEGF polymorphisms in the study population. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: April 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317200

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

Additional Information:
Publications:
Responsible Party: Nasser Hanna, M.D., Hoosier Oncology Group
ClinicalTrials.gov Identifier: NCT00317200     History of Changes
Other Study ID Numbers: HOG LUN05-99
Study First Received: April 20, 2006
Last Updated: April 28, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Bevacizumab
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014