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

NCT00079235 | Completed Phase 2

• 5 other identifiers: NCI-2012-01810N0323CDR0000355117NCCTG-N0323U10CA025224
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 5 years

Secondary Outcomes (4)

• Progression-free survival

  24 weeks

• Survival time

  Time from registration to death due to any cause, assessed up to 5 years

• Time to disease progression

  Time from registration to documentation of disease progression, assessed up to 5 years

• Effects of CCI-779 on mTOR as assessed by expression of 4EBP, phosphoAkt, p70S6kinase, eIF4E, cyclinD1, Her2, and EGFR

  Day 8

Study Arms (1)

Arm I

EXPERIMENTAL

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

Drug: temsirolimus; Other: laboratory biomarker analysis

Interventions

temsirolimus DRUG

Given IV

Also known as: CCI-779, cell cycle inhibitor 779, Torisel

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

temsirolimus; Sirolimus

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Alex Adjei

  North Central Cancer Treatment Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 10, 2004
• Study Start: February 1, 2004
• Primary Completion: June 1, 2007
• Last Updated: July 16, 2013

Record last verified: 2013-06

Locations

US (1)