CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell Lung Cancer
Completed · Phase 2
Conditions studied: Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
In brief
This phase II trial is studying how well CCI-779 works in treating patients with stage IIIB non small cell lung cancer (with pleural effusion) or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. CCI-779 may also stop the growth of tumor cells by blocking the enzymes necessary for their growth.
Key facts
- Study ID
- NCT00079235
- Run by
- National Cancer Institute (NCI)
- People needed
- 50
- Starts
- 2004-02-01
- Last updated by the study team
- 2013-07-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIB (with pleural effusion) or IV disease
- Measurable disease
- At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
- The following are not considered measurable disease:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Cystic lesions
- Abdominal masses that are not confirmed and followed by imaging techniques
- Blood and tissue blocks available
- Must have accessible tumor (i.e., superficial lesions such as lymph node, subcutaneous nodules) to provide core needle biopsy tissue before and during study treatment
- No known brain metastases
- Performance status - ECOG 0-2
- At least 12 weeks
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10 g/dL
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST ≤ 3 times ULN (5 times ULN if hepatic metastases are present)
- Creatinine ≤ 1.5 times ULN
- Serum fasting cholesterol ≤ 350 mg/dL
Where it is running
- North Central Cancer Treatment Group — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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