Carboplatin, Paclitaxel, Selenomethionine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Phase 2

Terminated

• Conditions: Lung Cancer
• Interventions: Dietary Supplement: selenomethionine; Drug: carboplatin; Drug: paclitaxel; Other: laboratory biomarker analysis; Radiation: radiation therapy

• Registration Number: NCT00526890
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with selenomethionine and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well selenomethionine works when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES:

Primary

* Determine the safety and tolerability of selenomethionine in combination with chemotherapy and radiotherapy in patients with unresectable stage IIIA or IIIB non-small cell lung cancer.

* Determine if the incidence of excessive adverse events, in the form of esophagitis, pneumonitis, and myelosuppression, can be reduced with this regimen.

Secondary

* Estimate response rate, failure-free survival, and overall survival of these patients.

* Correlate selenium levels with degree of observed adverse events.

OUTLINE: This is a multicenter study.

Patients receive oral selenomethionine twice daily for 1 week and then once daily for 6 weeks. Patients also receive paclitaxel IV over 1 hour once weekly and carboplatin IV over 30 minutes once weekly for 6 weeks and undergo radiotherapy 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and weekly during treatment and analyzed by absorption spectrophotometry for selenium measurement of drug concentration

After the completion of study treatment, patients are followed periodically.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-09-07
• Study First Submitted QC: 2007-09-07
• Study First Posted: 2007-09-10
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Results First Submitted: 2015-01-08
• Results First Submitted QC: 2015-01-08
• Results First Posted: 2015-01-15
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPSR	selenomethionine	Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
CPSR	carboplatin	Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
CPSR	paclitaxel	Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
CPSR	laboratory biomarker analysis	Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
CPSR	radiation therapy	Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation

Primary Outcome Measures

Name	Time	Method
Incidence of Grade 3-4 Myelosuppression	During study treatment, up to 6 weeks
Incidence of Grade 3-4 Pneumonitis	During study treatment, up to 6 weeks
Incidence of Grade 3-4 Esophagitis	During study treatment, up to 6 weeks

Secondary Outcome Measures

Name	Time	Method
Failure-free Survival	Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter.
Response Rate	1 month post-treatment, then q 3 months x 4	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Selenium Level by Incidence of SAE	Pre-treatment and every week for 6 weeks prior to chemotherapy.	Median Selenium level by Incidence of SAE. Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.
Overall Survival	Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States