CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell L… (NCT00079235) | Clinical Trial Compass
CompletedPhase 2
CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell Lung Cancer
United States50 participantsStarted 2004-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Serum fasting triglycerides ≤ 400 mg/dL
* HIV negative
* No uncontrolled infection
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or non-invasive carcinomas
* No concurrent severe underlying disease that would preclude study participation
* Not pregnant or nursing
* Negativ…
What they're measuring
1
Confirmed tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST)