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CompletedNCT00308529Updated Jun 22, 2010

Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Limited Stage Small Cell Lung Cancer

A Phase 2 interventional study of irinotecan and carboplatin in Carcinoma, Small Cell Lung and Lung Cancer, sponsored by SCRI Development Innovations, LLC. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-06-22.

Sponsored by SCRI Development Innovations, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
55
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This proposed phase II trial will investigate the combination of irinotecan, carboplatin and bevacizumab along with radiation in the treatment of patients with limited-stage SCLC. This study differs from our "maintenance" bevacizumab trial in that bevacizumab will begin with the initial chemotherapy treatment. Irinotecan/platinum regimens are emerging as standard treatments for patients with extensive-stage disease. Adding a novel minimally toxic agent to this regimen up front may further enhance this doublet's efficacy without contributing to toxicity. This trial will be one of the first clinical trials to evaluate a combination of targeted therapy and chemotherapy in the up front treatment of a common solid tumor.

Read the detailed description

Eligible patients will receive 4 courses of irinotecan, carboplatin, and bevacizumab. Radiation therapy will begin concurrently with the third course of systemic treatment. The intervals between chemotherapy courses will be 28 days.Patients will be completely restaged approximately 2 weeks after completion of chemotherapy prior to beginning treatment with maintenance bevacizumab. Those with progressive tumor or serious toxicity will come off study. Those with stable disease or objective tumor responses will continue treatment with restaging every 12 weeks for a minimum of 6 cycles (6 months).

  • Induction chemotherapy regimen Irinotecan: 60mg/m2 IV on days 1, 8, and 15 Carboplatin: AUC=4 day 1 only Bevacizumab 10 mg/kg IV days 1, 15 Cycles are repeated every 28 days for four courses
  • Radiation therapy 1.8 Gy, single daily fractions, concurrently with the third course of chemotherapy e to a total dose of 61.2 Gy (34 fractions). Patients obtaining complete remission or near complete remission will also receive prophylactic whole brain radiotherapy, given within one month after all therapy is completed (total dose 24Gy in 2Gy daily fractions).
  • Maintenance Bevacizumab Bevacizumab alone at a dose of 10 mg/kg IV days 1 and 15 each cycle, for a maximum of 6 additional cycles (6 months) with restaging every 12 weeks.
02

Conditions studied

  • Carcinoma, Small Cell Lung
  • Lung Cancer

Keywords

  • Carcinoma Small Cell Lung
  • Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 55 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

SCRI Development Innovations, LLC is the lead sponsor of 174 studies on the registry; 5 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically-confirmed small cell lung cancer.
  • Limited stage disease (
  • ECOG performance status 0 or 1.
  • No previous treatment with chemotherapy, radiation therapy, or biologic agents.
  • Measurable disease
  • Adequate bone marrow, liver, kidney function
  • Patients must be able to understand the nature of this study and give written consent.

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years
  • History of a prior malignancy within three years with the exception of skin cancer (excluding melanoma), cervical carcinoma in situ, in situ breast carcinoma, or early stage prostate cancer.
  • Women who are pregnant or lactating are ineligible. Men and women of childbearing potential are required to use adequate contraception during this study.
  • History or physical exam evidence of CNS disease (eg seizures not controlled with standard medical therapy, history of stroke)
  • Active infection requiring parenteral antibiotics
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or fine needle aspiration within 7 days of beginning bevacizumab or anticipation of need for major surgical procedure during the course of the study.
  • Full-dose oral or parenteral anticoagulation must be on a stable dosing schedule prior to enrollment.
  • Proteinuria
  • Serious nonhealing wound, ulcer, or bone fracture
  • Evidence of bleeding diathesis or coagulopathy
  • Prior hemoptysis.
  • History of acute myocardial infarction or stroke within 6 months
  • Uncontrolled hypertension (> 150/100), unstable angina, New York Heart Association grade II or greater CHF, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease.
  • Received other investigational drugs within 28 days
  • PEG, G-tubes, or other percutaneous drains/tubes
  • History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or place the subject at high risk for treatment complications
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the previous 6 months
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants

Interventions

  • Drugirinotecan
  • Drugcarboplatin
  • Drugbevacizumab
  • ProcedureRadiation Therapy
06

What researchers measure

Primary outcomes

  1. progression-free survival

Secondary outcomes

  1. toxicity

  2. overall response rate

  3. duration of response

  4. overall survival

07

Study locations

4 sites
  • Florida Cancer Specialists
    Fort Myers, Florida 33901, United States
  • Oncology Hematology Care
    Cincinnati, Ohio 45242, United States
  • Chattanooga Oncology Hematology Associates
    Chattanooga, Tennessee 37404, United States
  • Tennessee Oncology, PLLC
    Nashville, Tennessee 37023, United States
08

References and documents

Publications

  • Spigel DR, Hainsworth JD, Yardley DA, Raefsky E, Patton J, Peacock N, Farley C, Burris HA 3rd, Greco FA. Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol. 2010 Jan 1;28(1):43-8. doi: 10.1200/JCO.2009.24.7353. Epub 2009 Nov 9. PubMed 19901100 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00308529
Lead sponsor
SCRI Development Innovations, LLC
Collaborators
Genentech, Inc.
First posted
Mar 29, 2006
Start date
Mar 2006
Primary completion
Apr 2007
Completion
Jan 2009
Last update
Jun 22, 2010

Study contacts

David R. Spigel, MD
principal investigator · SCRI Development Innovations, LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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