Lung Neoplasms
Conditions
Brief summary
This is a Phase 2 study of pemetrexed and gemcitabine chemotherapy given once every 14 days to patients with advanced stage non-small cell lung cancer. This treatment is for patients that have not received any prior chemotherapy treatment for lung cancer. The primary goal is to find out if the tumor gets smaller or disappears with this treatment.
Interventions
DRUGpemetrexed
DRUGgemcitabine
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have a diagnosis of advanced stage non-small cell lung cancer. 2. Are able to be active at home and/or work. 3. Have not received chemotherapy for this cancer disease. 4. Have good organ function (for example, most blood work is normal). 5. Have completed any prior radiation treatment at least 4 weeks ago.
Exclusion criteria
1. Have been treated with an investigational/research drug within the last month. 2. Have cancer that has spread to the brain and is causing symptoms. 3. Have an active infection or other serious medical condition. 4. Have a second cancer in addition to non-small cell lung cancer. 5. Can not stop taking aspirin or other anti-inflammatory agents for 5-8 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To find out how often tumors become smaller or disappear in patients with advanced NSCLC treated with gemcitabine followed by pemetrexed once every 14 days. Chemotherapy treatment will be given for up to 12 times or until the cancer disease increases. | — |
Secondary
| Measure | Time frame |
|---|---|
| To measure the effects of chemotherapy treatment on: | — |
| time until the cancer becomes less;time to cancer re-appears or becomes larger;length of time there is no increase in the amount of cancer;length of time patients survive; | — |
| To measure the side-effects from this chemotherapy as given once every 14 days. | — |
Countries
United States
Outcome results
None listed