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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193375
• Other study ID #: SCRI LUN 72
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: October 11, 2012
• Start date: August 2003
• Est. completion date: May 2008

Study information

• Verified date: October 2012
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Irinotecan
50mg/m2 days 1 & 8 each 21-day cycle 1 & 2, 28-day cycle 3 & 4
• Carboplatin
AUC 5
• Bevacizumab
10mg/kg IV every 2 weeks for 10 doses starting week 16

Radiation:
• Radiation

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Genentech, Inc., Pharmacia and Upjohn

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months	Yes
Secondary	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.	18 months	No
Secondary	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.	18 month	No