Status:
COMPLETED
CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 che...
Detailed Description
OBJECTIVES: Primary I. Determine the response rate in patients with stage IIIB (with pleural effusion) or IV non-small cell lung cancer treated with CCI-779. II. Determine the clinical toxic effects ...
Eligibility Criteria
Inclusion
- 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
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study treatment
- No prior biologic therapy
- No prior gene therapy
- No prior immunotherapy
- No concurrent immunotherapy
- No concurrent prophylactic growth factors to support neutrophil count
- No prior chemotherapy for NSCLC except low-dose cisplatin as a radiosensitizer
- No other concurrent chemotherapy
- No concurrent dexamethasone (10 mg IV)
- No prior radiotherapy to 30% or more of bone marrow
- Concurrent radiotherapy for underlying malignancy and non-target sites (e.g., painful pre-existing bony metastasis) allowed
- No other concurrent investigational therapy
- No concurrent immunosuppressive therapy
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00079235
Start Date
February 1 2004
Last Update
July 16 2013
Active Locations (1)
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1
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905