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Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer

This study has been completed.
Genentech, Inc.
Pharmacia and Upjohn
Information provided by (Responsible Party):
SCRI Development Innovations, LLC Identifier:
First received: September 12, 2005
Last updated: June 29, 2016
Last verified: June 2016
In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with bevacizumab, in patients with limited stage small cell lung cancer.

Condition Intervention Phase
Lung Cancer
Drug: Irinotecan
Drug: Carboplatin
Drug: Bevacizumab
Radiation: Radiation
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Concurrent Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab (Avastin) in the Treatment of Patients With Limited Stage Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) [ Time Frame: 18 months ]
    Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3.

Secondary Outcome Measures:
  • 2-Year Progression-free Survival (PFS) [ Time Frame: 24 months ]
    Progression-free survival (PFS) was defined as the date of study entry until the date of tumor progression or death. 2-Year PFS is the percentage of patients alive and without progressive disease (PD) 2 years from the date of study entry.

  • Overall Response Rate [ Time Frame: 18 month ]
    Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.

Enrollment: 60
Study Start Date: August 2003
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
Drug: Irinotecan
50mg/m2 days 1 & 8 each 21-day cycle 1 & 2, 28-day cycle 3 & 4
Other Name: Camptosar
Drug: Carboplatin
Other Name: Paraplatin
Drug: Bevacizumab
10mg/kg IV every 2 weeks for 10 doses starting week 16
Other Name: Avastin
Radiation: Radiation

Detailed Description:

Upon determination of eligibility, all patients will be receive:

  • Irinotecan + Carboplatin + Radiation Therapy + Bevacizumab

Patients will receive 4 courses of irinotecan/carboplatin. Radiation therapy will begin concurrently with the third course of chemotherapy. The intervals between chemotherapy courses will be 21 days except for the interval between the third and fourth courses (during radiation therapy), which will be 28 days.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Small cell lung cancer, confirmed by biopsy.
  • Limited stage disease after standard evaluation.
  • Able to perform activities of daily living without assistance.
  • No previous treatment with chemotherapy, radiation therapy, or biologics.
  • Measurable or evaluable disease
  • Adequate bone marrow, liver and kidney function
  • Able to understand the nature of this study and give written consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Age < 18 years
  • History of previous malignancies
  • Women pregnant or lactating
  • History or physical exam evidence of central nervous system disease)
  • Active infection requiring intravenous antibiotics
  • Full-dose anticoagulation or thrombolytic therapy within 10 days
  • Proteinuria.
  • Serious nonhealing wound, ulcer, or bone fracture
  • Evidence if bleeding diathesis or coagulopathy
  • History of heart attack within 6 months.
  • Uncontrolled cardiovascular disease
  • PEG or G-tube
  • History of other serious disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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Please refer to this study by its identifier: NCT00193375

Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Pharmacia and Upjohn
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  More Information

Responsible Party: SCRI Development Innovations, LLC Identifier: NCT00193375     History of Changes
Other Study ID Numbers: SCRI LUN 72
Study First Received: September 12, 2005
Results First Received: October 5, 2012
Last Updated: June 29, 2016

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 24, 2017