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Completed

NCT Number: NCT00193375

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irinotecan

Drug

50mg/m2 days 1 & 8 each 21-day cycle 1 & 2, 28-day cycle 3 & 4

Other names: Camptosar

carboplatin

Drug

AUC 5

Other names: Paraplatin

Bevacizumab

Drug

10mg/kg IV every 2 weeks for 10 doses starting week 16

Other names: Avastin

Radiation

Radiation

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Genentech, Inc.
  • Pharmacia and Upjohn

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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