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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


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

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)

Outcome Description:

Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3.

Outcome Time Frame:

18 months

Safety Issue:

Yes

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LUN 72

NCT ID:

NCT00193375

Start Date:

August 2003

Completion Date:

May 2008

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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