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A Phase II Study of Cisplatin Plus Etoposide (PE) Plus Bevacizumab (NSC #704865) for Previously Untreated Extensive Stage Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase II Study of Cisplatin Plus Etoposide (PE) Plus Bevacizumab (NSC #704865) for Previously Untreated Extensive Stage Small Cell Lung Cancer


PRIMARY OBJECTIVES:

I. Determine the 6-month progression-free survival of patients with previously untreated
extensive stage small cell lung cancer treated with cisplatin, etoposide, and bevacizumab.

II. Determine the 6-month survival and response rate in patients treated with this regimen.

III. Determine the toxicity of this regimen in these patients.

SECONDARY OBJECTIVES:

I. Correlate pretreatment plasma levels of vascular endothelial growth factor (VEGF) with
response and progression-free and overall survival of patients treated with this regimen.

II. Correlate elevated plasma levels of endothelial cell-specific proteins (VCAM,
E-selectin) with response in patients treated with this regimen.

III. Correlate pre- and post-treatment plasma levels of basic fibroblast growth factor with
response and progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Chemotherapy: Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV
over 60 minutes on days 1-3. Treatment repeats every 21 days for up to 4 courses in the
absence of disease progression or unacceptable toxicity.

Bevacizumab therapy: Beginning concurrently with chemotherapy, patients receive bevacizumab
IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 17 courses (1 year)
in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks for up to 3 years from study entry.

Inclusion Criteria


Inclusion Criteria

- Histologically or cytologically confirmed small cell lung cancer, staged as extensive
disease

- Measurable disease per RECIST criteria

- Previously irradiated lesions must not be the sole site of measurable disease

- Age 18 and over

- ECOG Performance status 0-2

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- No history of hemorrhagic disorders

- Bilirubin ≤ 1.5 mg/dL

- PTT ≤ upper limit of normal

- INR ≤ 1.5

- Creatinine ≤ 1.5 mg/dL

- Proteinuria < 1+. For proteinuria ≥ 1+, urine protein must be ≤ 1 g/24 hours

- Hypertension must be well-controlled (≤ 150/85) on a stable regimen of
antihypertensive therapy

- Not pregnant or nursing - patient must have negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
treatment

Exclusion Criteria

- Prior radiotherapy to the site of evaluable disease

- CNS metastases by CT scan or MRI within the past 4 weeks

- Symptomatic congestive heart failure

- Cardiac arrhythmia

- History of thrombotic disorders

- Clinically significant peripheral artery disease

- Arterial thromboembolic event within the past 6 months, including transient ischemic
attack, cerebrovascular accident, unstable angina, or myocardial infarction

- History of gross hemoptysis (i.e., ≥ 1 teaspoon of bright red blood)

- Other malignancy within the past 5 years except cured basal cell or squamous cell
skin cancer or carcinoma in situ of the cervix

- Ongoing or active infection

- Psychiatric illness or social situation that would preclude study compliance

- Serious nonhealing wound, ulcer, or bone fracture

- Prior immunotherapy for lung cancer

- Prior biologic therapy for lung cancer

- Prior chemotherapy for lung cancer

- Concurrent local radiotherapy for pain control or life-threatening situations

- Prior major surgery within 28 days

- Prior minor surgery or needle biopsies within 7 days

- Concurrent chronic daily aspirin (> 325 mg/day)

- Concurrent nonsteroidal anti-inflammatory agents known to inhibit platelet function

- Concurrent therapeutic anticoagulation, but prophylactic anticoagulation of venous
access devices is allowed

- Concurrent treatment with Dipyridamole, Ticlopidine, Clopidogrel, Cilostazol

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants Alive and Progression-free (PF) at 6 Months

Outcome Description:

Progression-free survival was defined to be the interval in months from the date of registration to the date of documented disease progression or to death without progression. Patients alive without progression at 6 months were included in the numerator when calculating the progression-free rate.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Alan B. Sandler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02944

NCT ID:

NCT00079040

Start Date:

June 2004

Completion Date:

January 2009

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Akron City HospitalAkron, Ohio  44304
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
CCOP - Colorado Cancer Research ProgramDenver, Colorado  80224-2522
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
St. Mary - Corwin Regional Medical CenterPueblo, Colorado  81004
North Suburban Medical CenterThornton, Colorado  80229
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Southwest Medical CenterLiberal, Kansas  67901
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
William N. Wishard Memorial HospitalIndianapolis, Indiana  46202
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921