Frailty Index and Geriatric Assessment in Predicting Toxicity to Front-Line Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

Wake Forest University (WFU)

Status: Completed

Conditions: Stage IV Non-small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer

Treatments: Drug: cisplatin; Other: questionnaire administration; Drug: carboplatin

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01026467

CCCWFU 98709 (Other Identifier)

IRB00011804

NCI-2009-01451 (Registry Identifier)

Details and patient eligibility

About

This phase II trial is studying how well a frailty index and geriatric assessment works in predicting toxicity to front-line chemotherapy in treating patients with stage IV non-small cell lung cancer. A frailty index and geriatric assessment prior to treatment may help identify a better treatment regimen

Full description

PRIMARY OBJECTIVE:

I. To determine the correlation of the data from the frailty index and geriatric assessment tool with the level of toxicity encountered in the first two cycles of therapy.

OUTLINE:

Patients complete a frailty index and geriatric assessment prior to beginning chemotherapy. Patients receive standard-of-care chemotherapy comprising carboplatin intravenously (IV) and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 2 courses.

Enrollment: 45 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Pathological documentation of non-small cell lung cancer Stage IV disease Prior adjuvant chemotherapy for the earlier stages of non-small cell lung cancer is allowed Patients with brain metastases are allowed on protocol only if they have received brain irradiation and are neurologically stable Patients with other malignancies are allowed on protocol unless they are receiving active treatment (surgery, radiation, chemotherapy or immunotherapy) for the other malignancy Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

Prior palliative chemotherapy Pregnant and/or lactating women Prior radiation therapy other than brain irradiation for brain metastases

Trial design

45 participants in 1 patient group

Supportive Care (frailty index, geriatric assessment, chemo)

Description:

Patients complete a frailty index and geriatric assessment prior to beginning chemotherapy. Patients receive standard-of-care chemotherapy comprising carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 2 courses

Treatment:

Other: questionnaire administration

Drug: carboplatin

Drug: cisplatin