CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell Lung Cancer
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
- Determine the clinical toxic effects of this drug in these patients.
Secondary I. Determine the 24-week progression-free survival rate in patients treated with this drug.
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Determine the time to progression and overall survival of patients treated with this drug.
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Evaluate predictive markers of activity (e.g., PTEN mutations and phosphoAkt expression) of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 25-55 patients will be accrued for this study within 12 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. |
Drug: temsirolimus
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
Outcome Measures
Primary Outcome Measures
- Confirmed tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST) [Up to 5 years]
Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.
Secondary Outcome Measures
- Progression-free survival [24 weeks]
Computed and binomial confidence intervals for the true success proportion will be calculated.
- Survival time [Time from registration to death due to any cause, assessed up to 5 years]
Estimated using the method of Kaplan-Meier.
- Time to disease progression [Time from registration to documentation of disease progression, assessed up to 5 years]
Estimated using the method of Kaplan-Meier.
- Effects of CCI-779 on mTOR as assessed by expression of 4EBP, phosphoAkt, p70S6kinase, eIF4E, cyclinD1, Her2, and EGFR [Day 8]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
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Stage IIIB (with pleural effusion) or IV disease
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Measurable disease
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At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
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The following are not considered measurable disease:
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Bone lesions
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Leptomeningeal disease
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Ascites
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Pleural/pericardial effusion
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Inflammatory breast disease
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Lymphangitis cutis/pulmonis
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Cystic lesions
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Abdominal masses that are not confirmed and followed by imaging techniques
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Blood and tissue blocks available
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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
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No known brain metastases
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Performance status - ECOG 0-2
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At least 12 weeks
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Absolute neutrophil count ≥ 1,500/mm^3
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Platelet count ≥ 100,000/mm^3
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Hemoglobin ≥ 10 g/dL
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Bilirubin ≤ 2 times upper limit of normal (ULN)
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AST ≤ 3 times ULN (5 times ULN if hepatic metastases are present)
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Creatinine ≤ 1.5 times ULN
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Serum fasting cholesterol ≤ 350 mg/dL
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Serum fasting triglycerides ≤ 400 mg/dL
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HIV negative
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No uncontrolled infection
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No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or non-invasive carcinomas
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No concurrent severe underlying disease that would preclude study participation
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception during and for 3 months after study treatment
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No prior biologic therapy
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No prior gene therapy
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No prior immunotherapy
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No concurrent immunotherapy
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No concurrent prophylactic growth factors to support neutrophil count
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No prior chemotherapy for NSCLC except low-dose cisplatin as a radiosensitizer
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No other concurrent chemotherapy
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No concurrent dexamethasone (10 mg IV)
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No prior radiotherapy to 30% or more of bone marrow
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Concurrent radiotherapy for underlying malignancy and non-target sites (e.g., painful pre-existing bony metastasis) allowed
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No other concurrent investigational therapy
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No concurrent immunosuppressive therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | North Central Cancer Treatment Group | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Alex Adjei, North Central Cancer Treatment Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2012-01810
- N0323
- CDR0000355117
- NCCTG-N0323
- U10CA025224