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

SCRI Development Innovations

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Radiation: Radiation; Drug: Bevacizumab; Drug: Irinotecan; Drug: Carboplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00193375

SCRI LUN 72

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Intervention

Experimental group

Description:

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).

Treatment:

Drug: Carboplatin

Radiation: Radiation

Drug: Bevacizumab

Drug: Irinotecan