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

This study has been terminated.
(lack of efficacy)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00526890
First Posted: September 10, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roswell Park Cancer Institute
  Purpose

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.


Condition Intervention Phase
Lung Cancer Dietary Supplement: selenomethionine Drug: carboplatin Drug: paclitaxel Other: laboratory biomarker analysis Radiation: radiation therapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination With Radiation for Patients With Unresectable Stage III Non-Small Cell Lung Cancer: A Phase II, Multi-Center Trial

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Incidence of Grade 3-4 Esophagitis [ Time Frame: During study treatment, up to 6 weeks ]
  • Incidence of Grade 3-4 Pneumonitis [ Time Frame: During study treatment, up to 6 weeks ]
  • Incidence of Grade 3-4 Myelosuppression [ Time Frame: During study treatment, up to 6 weeks ]

Secondary Outcome Measures:
  • Response Rate [ Time Frame: 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.

  • Failure-free Survival [ Time Frame: Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter. ]
  • Overall Survival [ Time Frame: Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter ]
  • Correlation of Selenium Levels With Degree of Observed Adverse Events [ Time Frame: Pre-treatment and every week for 6 weeks prior to chemotherapy. ]
    Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events. There was no significant correlation between selenium levels and serious adverse events (P=0.3149)


Enrollment: 16
Study Start Date: October 2006
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CPSR
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
Dietary Supplement: selenomethionine
Oral Twice daily
Drug: carboplatin
Weekly IV
Drug: paclitaxel
Weekly IV
Other: laboratory biomarker analysis
Correlative Study
Radiation: radiation therapy
Undergoing radiation Therapy

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologic subtypes:

    • Squamous cell carcinoma
    • Adenocarcinoma (including bronchoalveolar cell carcinoma)
    • Large cell anaplastic carcinoma (including giant and clear cell carcinoma)
  • Stage IIIA disease OR selected stage IIIB disease

    • T1-2, N2 disease OR T3, N2 or T4, N0-N2 disease (if based on tumor closeness to the carina, invasion of the mediastinum, or invasion of the chest wall)

      • Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in the radiation boost field
  • Tumors adjacent to a vertebral body allowed unless there is demonstrable bone invasion

    • All gross disease must be able to be encompassed in the radiation boost field
    • No direct invasion of a vertebrae body
  • Unresectable or inoperable disease
  • Measurable disease
  • Suitable for radiotherapy, as deemed by the radiation oncologist
  • No scalene, supraclavicular, or contralateral hilar node involvement
  • Pleural effusion allowed provided it is transudate, cytologically negative, and non-bloody, and, according to the radiation oncologist, the tumor can be encompassed within a reasonable radiation field

    • Pleural effusion seen on chest CT scan, but not on chest x-ray, that is too small to tap is allowed
    • No exudative, bloody, or cytologically malignant effusions
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Total bilirubin ≤ 1.5 mg/dL
  • Creatinine normal
  • Alkaline phosphatase AND AST or ALT meeting 1 of the following criteria:

    • Alkaline phosphatase normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
    • Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
    • Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal
  • Able to swallow oral medications
  • No peripheral neuropathy > grade 1
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to selenomethionine or agents formulated with Cremophor EL
  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Clinically significant cardiac arrhythmia
    • Psychiatric illness or social situations that would limit compliance with study requirements
  • No currently "active" second malignancy other than non-melanoma skin cancer

    • Patients are considered not to have an "active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • At least 2 weeks since prior formal exploratory thoracotomy (N2 node identified making patient ineligible for surgery)
  • No prior chemotherapy or radiotherapy for NSCLC
  • No prior taxanes or platinum drugs
  • No other concurrent investigational agents or anticancer therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent chemotherapy or hormonal therapy, except for the following:

    • Steroids administered for adrenal failure or septic shock
    • Hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
    • Glucocorticosteroids administered as antiemetics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526890


Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Jorge Gomez, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00526890     History of Changes
Other Study ID Numbers: CDR0000562780
RPCI-I-65605
First Submitted: September 7, 2007
First Posted: September 10, 2007
Results First Submitted: January 8, 2015
Results First Posted: January 15, 2015
Last Update Posted: October 12, 2017
Last Verified: September 2017

Keywords provided by Roswell Park Cancer Institute:
squamous cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
large cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
adenosquamous cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Selenium
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances