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Recurrent Non-small Cell Lung CancerPhase 2NCT00079235

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

A Phase 2 study testing temsirolimus and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
temsirolimus and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Feb 2004to Jun 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 45Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Central Cancer Treatment Group

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase II Study of the mTOR Inhibitor, CCI-779 in Patients With Advanced Non-Small Cell Lung Cancer

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.

Read the 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.

Being tested
temsirolimus, laboratory biomarker analysis
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • temsirolimusDrug

    Also called CCI-779, cell cycle inhibitor 779, Torisel

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00079235
Study groupRoleWhat they receive
Arm IExperimentalPatients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22.
Receives: Drug: temsirolimus; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 5 years

Secondary outcomes (4)

  1. Progression-free survival

    Computed and binomial confidence intervals for the true success proportion will be calculated.

    Measured: 24 weeks

  2. Survival time

    Estimated using the method of Kaplan-Meier.

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

  3. Time to disease progression

    Estimated using the method of Kaplan-Meier.

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

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

    Measured: Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2004 (estimated)
  2. Study startFeb 2004
  3. Primary completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00079235
Sponsor's protocol ID
NCI-2012-01810
Other IDs
N0323, CDR0000355117, NCCTG-N0323, U10CA025224
Status last verified
Jun 2013
First submitted
8 Mar 2004
Last updated
16 Jul 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing temsirolimus and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 45 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00079235.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2013.

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