CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

Criteria

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