Expired Study
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Rochester, Minnesota 55905


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

NCI-2012-01810


NCT ID:

NCT00079235


Secondary ID:

N0323


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Actual


Overall Contact Information

Official Name:Alex Adjei
Principal Investigator
North Central Cancer Treatment Group

Study Dates

Start Date:February 2004
Primary Completion Date:June 2007
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:July 15, 2013
First Received Date:March 8, 2004

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Effects of CCI-779 on mTOR as assessed by expression of 4EBP, phosphoAkt, p70S6kinase, eIF4E, cyclinD1, Her2, and EGFR
Time Frame:Day 8
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to disease progression
Time Frame:Time from registration to documentation of disease progression, assessed up to 5 years
Safety Issues:False
Description:Estimated using the method of Kaplan-Meier.
Outcome Type:Secondary Outcome
Measure:Survival time
Time Frame:Time from registration to death due to any cause, assessed up to 5 years
Safety Issues:False
Description:Estimated using the method of Kaplan-Meier.
Outcome Type:Secondary Outcome
Measure:Progression-free survival
Time Frame:24 weeks
Safety Issues:False
Description:Computed and binomial confidence intervals for the true success proportion will be calculated.
Outcome Type:Primary Outcome
Measure:Confirmed tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame:Up to 5 years
Safety Issues:False
Description:Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.

Study Interventions

Intervention Type:Drug
Name:temsirolimus
Description:Given IV
Arm Name:Arm I
Other Name:CCI-779
Intervention Type:Other
Name:laboratory biomarker analysis
Description:Correlative studies
Arm Name:Arm I

Study Arms

Study Arm Type:Experimental
Arm Name:Arm I
Description:Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Reungwetwattana T, Molina JR, Mandrekar SJ, Allen-Ziegler K, Rowland KM, Reuter NF, Luyun RF, Dy GK, Marks RS, Schild SE, Jett JR, Adjei AA. Brief Report: A Phase II "Window-of-Opportunity" Frontline Study of the mTOR Inhibitor, Temsirolimus Given as a Single Agent in Patients with Advanced NSCLC, an NCCTG Study. J Thorac Oncol. 2012 May;7(5):919-22. PubMed
PMID:22722792

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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