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

Phase 2CompletedNCT00193375

SCRI Development Innovations, LLC60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

IrinotecanDRUG

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

CarboplatinDRUG

AUC 5

BevacizumabDRUG

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

Radiation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

Time frame: 18 months

Secondary Outcomes

2-Year Progression-free Survival (PFS)

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.

Time frame: 24 months

Overall Response Rate

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.

Time frame: 18 month

Data from ClinicalTrials.gov

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