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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of esophagitis, pneumonitis, and myelosuppression

Safety Issue:

No

Principal Investigator

Nithya Ramnath, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CDR0000562780

NCT ID:

NCT00526890

Start Date:

October 2006

Completion Date:

September 2010

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263