Clinical trial · Interventional

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

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

NCT00193375CI-TRIAL-00023415completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Bevacizumab	Drug	Bevacizumab	ALIAS
Carboplatin	Drug	Carboplatin	ALIAS
Irinotecan	Drug	Irinotecan	ALIAS
Radiation	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Intervention
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).
interventionNames
1. Drug: Irinotecan
2. Drug: Carboplatin
3. Drug: Bevacizumab
4. Radiation: Radiation

Primary outcomes (1)

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

Secondary outcomes (2)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (1)

BACKGROUNDSpigel 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. PMID 19875975