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

NCT00526890 | Terminated Phase 2 Results DMC

• 2 other identifiers: CDR0000562780RPCI-I-65605
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Incidence of Grade 3-4 Esophagitis

  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 Myelosuppression

  During study treatment, up to 6 weeks

Secondary Outcomes (4)

• Response Rate

  1 month post-treatment, then q 3 months x 4

• 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.

• 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

• Selenium Level by Incidence of SAE

  Pre-treatment and every week for 6 weeks prior to chemotherapy.

Study Arms (1)

CPSR

EXPERIMENTAL

Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation

Dietary Supplement: selenomethionine; Drug: carboplatin; Drug: paclitaxel; Other: laboratory biomarker analysis; Radiation: radiation therapy

Interventions

selenomethionine DIETARY_SUPPLEMENT

Oral Twice daily

CPSR

carboplatin DRUG

Weekly IV

CPSR

paclitaxel DRUG

Weekly IV

CPSR

laboratory biomarker analysis OTHER

Correlative Study

CPSR

radiation therapy RADIATION

Undergoing radiation Therapy

CPSR

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar; Carcinoma, Non-Small-Cell Lung

Interventions

Selenomethionine; Carboplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Organoselenium Compounds; Organic Chemicals; Methionine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Coordination Complexes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Jorge Gomez, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 10, 2007
• Study Start: October 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 28, 2017
• Results First Posted: January 15, 2015

Record last verified: 2017-10

Locations

US (1)