Clinical trial NCT00526890: Carboplatin, Paclitaxel, Selenomethionine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: 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
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Incidence of Grade 3-4 Esophagitis
timeFrame: During study treatment, up to 6 weeks
measure: Incidence of Grade 3-4 Pneumonitis
timeFrame: During study treatment, up to 6 weeks
measure: Incidence of Grade 3-4 Myelosuppression
timeFrame: During study treatment, up to 6 weeks
Secondary outcomes:
measure: Response Rate
timeFrame: 1 month post-treatment, then q 3 months x 4
measure: Failure-free Survival
timeFrame: Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter.
measure: Overall Survival
timeFrame: Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter
measure: Selenium Level by Incidence of SAE
timeFrame: Pre-treatment and every week for 6 weeks prior to chemotherapy.
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Jorge Gomez, MD
role: PRINCIPAL_INVESTIGATOR
References: