Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI NCCTG-N0323 N0323, NCT00079235

Objectives

Primary

1. Determine the response rate in patients with stage IIIB (with pleural effusion) or IV non-small cell lung cancer treated with CCI-779.
2. Determine the clinical toxic effects of this drug in these patients.

Secondary

1. Determine the 24-week progression-free survival rate in patients treated with this drug.
2. Determine the time to progression and overall survival of patients treated with this drug.
3. Evaluate predictive markers of activity (e.g., PTEN mutations and phosphoAkt expression) of this drug in these patients.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

• No prior biologic therapy
• No prior gene therapy
• No prior immunotherapy
• No concurrent immunotherapy
• No concurrent prophylactic growth factors to support neutrophil count

Chemotherapy

• No prior chemotherapy for NSCLC except low-dose cisplatin as a radiosensitizer
• No other concurrent chemotherapy

Endocrine therapy

• No concurrent dexamethasone (10 mg IV)

Radiotherapy

• 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

Surgery

• Not specified

Other

• No other concurrent investigational therapy
• No concurrent immunosuppressive therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• AST ≤ 3 times ULN (5 times ULN if hepatic metastases are present)

Renal

• Creatinine ≤ 1.5 times ULN

Other

• 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

Expected Enrollment

A total of 25-55 patients will be accrued for this study within 12 months.

Outcomes

Confirmed response

Progression-free survival at 24 weeks
Survival time
Time to disease progression
Effects of CCI-779 on mTOR

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Alex Adjei, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Donald Northfelt, MD, FACP, Protocol co-chair		Ph: 480-301-8335 Email: northfelt.donald@mayo.edu
Jann Sarkaria, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
Official Title		A Phase II Study of the mTOR Inhibitor, CCI-779 in Patients With Advanced Non-Small Cell Lung Cancer
Trial Start Date		2004-02-27
Registered in ClinicalTrials.gov		NCT00079235
Date Submitted to PDQ		2004-01-29
Information Last Verified		2007-01-12
NCI Grant/Contract Number		CA25224

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