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Recurrent Non-small Cell Lung CancerPhase 2NCT00062101

Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer

A Phase 2 study testing erlotinib hydrochloride, celecoxib 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 giving erlotinib together with celecoxib works in treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer. Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
erlotinib hydrochloride, celecoxib and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
Jan 2004to Jan 2006
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
  • Stage IIIB (malignant pleural effusion only) or IV
  • Recurrent disease that has progressed after 1 or 2 prior chemotherapy regimens (platinum- or nonplatinum-based)
  • At least 1 unidimensionally measurable lesion*
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Must have tissue specimen available for assays
Show all 73Show fewer
  • No brain metastases
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 3 months
  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper normal limit (ULN)
  • Creatinine normal
  • Creatinine clearance at least 60 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No prior abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
  • No congenital abnormality (e.g., Fuch's dystrophy)
  • No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
  • No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
  • Able to ingest oral medication
  • No requirement for IV alimentation
  • No history of peptic ulcer disease
  • No active gastrointestinal ulcers
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other concurrent uncontrolled illness
  • No ongoing or active infection
  • No significant traumatic injury within the past 21 days
  • No psychiatric illness or social situation that would preclude study compliance
  • No prior allergic reactions to sulfonamides, aspirin, and other nonsteroidal anti-inflammatory drugs
  • No prior monoclonal antibodies to epidermal growth factor receptor (EGFR)
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No concurrent chemotherapy
  • No concurrent glucocorticoids
  • More than 4 weeks since prior radiotherapy and recovered
  • More than 21 days since prior major surgery
  • No prior surgery affecting absorption
  • No prior EGFR-specific tyrosine kinases
  • No concurrent anticonvulsants
  • No other concurrent investigational agents
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No concurrent antacids
  • No concurrent administration of any of the following drugs:
  • Amiodarone
  • Chloramphenicol
  • Cimetidine
  • Fluvoxamine
  • Omeprazole
  • Zafirlukast
  • Clopidogrel
  • Cotrimoxazole
  • Disulfiram
  • Fluconazole
  • Fluoxetine
  • Fluvastatin
  • Fluvoxamine
  • Isoniazid
  • Itraconazole
  • Ketoconazole
  • Leflunomide
  • Metronidazole
  • Modafinil
  • Paroxetine
  • Phenylbutazone
  • Sertraline
  • Ticlopidine
  • Valproic acid

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rush University Medical Center

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: A Phase II Study of OSI 774 (IND Number 63383) in Combination With Celecoxib (Celebrex, Pharmacia) as Second-Line Therapy in Advanced Non-Small Cell Lung Cancer

This phase II trial is studying how well giving erlotinib together with celecoxib works in treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer. Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of a tumor by stopping blood flow to the tumor. Combining erlotinib with celecoxib may kill more tumor cells.

.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the response rate of patients with stage IIIB or IV recurrent non-small cell lung cancer treated with erlotinib and celecoxib as second-line therapy.

SECONDARY OBJECTIVES:

  1. Determine the time to progression in patients treated with this regimen. II. Determine the survival duration of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Correlate the expression of epidermal growth factor receptor and cyclooxygenase-2 in tumor specimens with response, time to progression, and survival in patients treated with this regimen.

OUTLINE: Patients are assigned to 1 of 2 treatment groups.

Group 1: Patients receive oral erlotinib once daily and oral celecoxib twice daily.

Group 2: Patients receive erlotinib as in group 1.

Treatment in both groups continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 10 months.

Being tested
erlotinib hydrochloride, celecoxib, 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.

  • erlotinib hydrochlorideDrug

    Also called CP-358,774, erlotinib, OSI-774

    Given orally (PO)

  • celecoxibDrug

    Also called Celebrex, SC-58635

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00062101
Study groupRoleWhat they receive
Group I (erlotinib hydrochloride, celecoxib)ExperimentalPatients receive oral erlotinib once daily and oral celecoxib twice daily.
Receives: Drug: erlotinib hydrochloride; Drug: celecoxib; Other: laboratory biomarker analysis
Group II (erlotinib hydrochloride)ExperimentalPatients receive erlotinib as in group 1.
Receives: Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis

What is being measured

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

  1. Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)

    Measured: From the start of treatment until disease progression/recurrence, assessed up to 5 years

Secondary outcomes (4)

  1. Time to progression

    Will be analyzed by calculating Kaplan Meier curves and estimating medians and 95% confidence intervals using the method of Brookmeyer and Crowley.

    Measured: Interval between start of treatment with erlotinib hydrochloride and celecoxib and the date on which progressive disease, assessed up to 5 years

  2. Overall survival

    Will be analyzed by calculating Kaplan Meier curves and estimating medians and 95% confidence intervals using the method of Brookmeyer and Crowley.

    Measured: Up to 5 years

  3. Relationship between measures of treatment efficacy and EGFR and COX-2 levels

    Measured: Up to 5 years

  4. Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0

    Measured: Up to 5 years

Timeline

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

  1. First posted6 Jun 2003 (estimated)
  2. Study startJan 2004
  3. Primary completionJan 2006

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00062101
Sponsor's protocol ID
NCI-2012-02720
Other IDs
LUNG 2002-01, NCI-5416, CDR0000304495
Status last verified
Jun 2013
First submitted
5 Jun 2003
Last updated
6 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib hydrochloride, celecoxib 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 73 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 6 Jun 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?

Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: From the start of treatment until disease progression/recurrence, assessed 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 NCT00062101.

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 6 Jun 2013.

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