Clinical trial NCT00193375: Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Pharmacia and Upjohn
First posted: 2005-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)
timeFrame: 18 months
Secondary outcomes:
measure: 2-Year Progression-free Survival (PFS)
timeFrame: 24 months
measure: Overall Response Rate
timeFrame: 18 month
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spigel DR, Greco FA, Zubkus JD, Murphy PB, Saez RA, Farley C, Yardley DA, Burris HA 3rd, Hainsworth JD. Phase II trial of irinotecan, carboplatin, and bevacizumab in the treatment of patients with extensive-stage small-cell lung cancer. J Thorac Oncol. 2009 Dec;4(12):1555-60. doi: 10.1097/JTO.0b013e3181bbc540.