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

Primary Purpose

Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temsirolimus
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Central Cancer Treatment Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22.

Outcomes

Primary Outcome Measures

Confirmed tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.

Secondary Outcome Measures

Progression-free survival
Computed and binomial confidence intervals for the true success proportion will be calculated.
Survival time
Estimated using the method of Kaplan-Meier.
Time to disease progression
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

Full Information

First Posted
March 8, 2004
Last Updated
July 15, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00079235
Brief Title
CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell Lung Cancer
Official Title
A Phase II Study of the mTOR Inhibitor, CCI-779 in Patients With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. 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.
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 of this drug in these patients. Secondary I. Determine the 24-week progression-free survival rate in patients treated with this drug. II. Determine the time to progression and overall survival of patients treated with this drug. III. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22.
Intervention Type
Drug
Intervention Name(s)
temsirolimus
Other Intervention Name(s)
CCI-779, cell cycle inhibitor 779, Torisel
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Confirmed tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Description
Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Computed and binomial confidence intervals for the true success proportion will be calculated.
Time Frame
24 weeks
Title
Survival time
Description
Estimated using the method of Kaplan-Meier.
Time Frame
Time from registration to death due to any cause, assessed up to 5 years
Title
Time to disease progression
Description
Estimated using the method of Kaplan-Meier.
Time Frame
Time from registration to documentation of disease progression, assessed up to 5 years
Title
Effects of CCI-779 on mTOR as assessed by expression of 4EBP, phosphoAkt, p70S6kinase, eIF4E, cyclinD1, Her2, and EGFR
Time Frame
Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Adjei
Organizational Affiliation
North Central Cancer Treatment Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Central Cancer Treatment Group
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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

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