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

Phase 2
18 Years
Not Enrolling
Small Cell Lung Cancer

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Trial Information

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

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


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

ECOG Performance Status 0 or 1


- 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


- Bilirubin < 1.5 x ULN

- Aspartate aminotransferase (AST, SGOT) < 2.5 x ULN


- Urine protein:creatinine ratio <1.0


- 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

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

To determine progression free survival(PFS) of this regimen in patients with chemosensitive relapsed small cell lung cancer (SCLC).

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Nasser Hanna, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, LLC


United States: Food and Drug Administration

Study ID:

HOG LUN05-99



Start Date:

April 2006

Completion Date:

November 2007

Related Keywords:

  • Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Highlands Oncology GroupSpringdale, Arkansas  72764
Siteman Cancer CenterSaint Louis, Missouri  63110
Center for Cancer Care at Goshen Health SystemGoshen, Indiana  46526
Methodist Cancer CenterOmaha, Nebraska  68114
Arnett Cancer CareLafayette, Indiana  47904
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Cancer Care Center Of Southern IndianaBloomington, Indiana  47403
Oncology Hematology Associates of SW IndianaEvansville, Indiana  47714
Community Regional Cancer CenterIndianapolis, Indiana  46256
Quality Cancer Center (MCGOP)Indianapolis, Indiana  46202
Medical Consultants, P.C.Muncie, Indiana  47303
Center for Cancer Care, Inc., P.C.New Albany, Indiana  47150
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana  46815
Pennsylvania Oncology-Hematology AssociatesPhiladelphia, Pennsylvania  19106
Fox Chase Cancer Center Extramural Research ProgramRockledge, Pennsylvania  19046