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Lung CancerPhase 1/2NCT00073866

Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer

A Phase 1/2 study testing celecoxib, docetaxel and irinotecan hydrochloride in people with Lung Cancer, run by Northwestern University at 3 sites 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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Combining celecoxib with combination chemotherapy may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
celecoxib, docetaxel and irinotecan hydrochloride
How many people
Not given
Where
3 sitesUnited States
Study dates
Jun 2003to Dec 2004
Phase
Phase 1/2
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

DISEASE CHARACTERISTICS:

  • Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
  • Stage IV
  • Stage IIIB with a malignant pleural effusion
  • Locally recurrent and/or persistent disease after locoregional therapy with or without systemic chemotherapy
  • Unidimensionally measurable disease
  • If the only site of measurable disease is in a previously irradiated area must have documented progression of disease in that area
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST and ALT less than 2.5 times upper limit of normal (ULN) (if alkaline phosphatase is normal)
  • Alkaline phosphatase less than 4 times ULN (if AST and ALT are normal)

Renal

  • Creatinine less than 2.0 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study treatment
  • No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
  • No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days
  • No prior hypersensitivity to cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, sulfonamides, or drugs formulated with polysorbate 80
  • No pre-existing grade 2 or greater peripheral neuropathy
  • No concurrent medical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 1 week since prior biologic therapy
  • Phase I patients:
  • Any number of prior biologic therapies allowed (e.g., chimeric antibodies or kinase inhibitors)
  • Phase II patients:
  • No prior biologic therapy for recurrent/metastatic disease
  • No concurrent filgrastim (G-CSF)

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • No prior irinotecan or docetaxel
  • Phase I patients:
  • Up to 2 prior chemotherapy regimens for recurrent/metastatic disease allowed (chemonaïve patients are also eligible)
  • Phase II patients:
  • At least 1 year since prior adjuvant or neoadjuvant chemotherapy for stage I-IIIA disease
  • No prior chemotherapy for recurrent/metastatic disease

Endocrine therapy

  • Less than 2 weeks of cumulative oral/IV corticosteroid use within the past 3 months

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • At least 3 weeks since prior extensive-field radiotherapy for recurrent/metastatic disease

Surgery

  • Recovered from prior surgery

Other

  • More than 60 days since prior treatment for peptic ulcer disease or gastritis/esophagitis
  • No prior NSAIDs at a frequency of more than 3 times per week for a cumulative period of more than 2 weeks within the past 30 days
  • No concurrent antiepileptics, cyclosporine, aspirin, or fluconazole
  • No concurrent NSAIDs
  • No other concurrent COX-2 inhibitors

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Evanston Northwestern Health Care - Evanston Hospital

    Evanston, Illinois, 60201

  • Silver Cross Hospital

    Joliet, Illinois, 60432

Other trials in United States

About this study

Official title: Phase I/II Trial Of Weekly Irinotecan And Docetaxel With The Addition Of Celecoxib In Advanced Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Combining celecoxib with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan and docetaxel when given together with celecoxib and to see how well they work in treating patients with advanced non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

  • Determine the recommended phase II dose of docetaxel and irinotecan in combination with celecoxib in patients with advanced non-small cell lung cancer.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the response rate of patients treated with this regimen.
  • Determine the progression-free and overall survival of patients treated with this regimen.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Correlate angiogenesis markers (intratumoral microvessel density and vascular endothelial growth factor [VEGF] expression and serum VEGF) and cyclooxygenase-2 expression with response and survival in patients treated with this regimen.
  • Correlate UGT1A1 genotype and CYP3A4 activity with the toxic effects of this regimen in these patients.

OUTLINE: This is a dose-escalation study of docetaxel and irinotecan.

  • Phase I: Patients receive docetaxel IV over 60 minutes and irinotecan IV over 30 minutes on days 1 and 8. Patients also receive oral celecoxib twice daily beginning on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of docetaxel and irinotecan until the recommended phase II dose is determined. The recommended phase II dose is defined as the highest dose at which 0 of 3 or 1 of 6 patients experience dose-limiting toxicity.
  • Phase II: Patients receive treatment as in phase I at the recommended phase II dose.

Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 3-70 patients (3-36 for phase I and 16-34 for phase II) will be accrued for this study.

Conditions
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

Timeline

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

  1. First posted11 Dec 2003 (estimated)
  2. Study startJun 2003
  3. Primary completionDec 2004
  4. Study completionDec 2004

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 1/2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00073866
Sponsor's protocol ID
NU 01L2
Other IDs
NU-01L2, PHARMACIA-NU-01L2
Status last verified
Jul 2012
First submitted
10 Dec 2003
Last updated
19 Jul 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Argiris A, Kut V, Luong L, Avram MJ. Phase I and pharmacokinetic study of docetaxel, irinotecan, and celecoxib in patients with advanced non-small cell lung cancer. Invest New Drugs. 2006 May;24(3):203-12. doi: 10.1007/s10637-005-3259-4.

    PubMed 16096702

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing celecoxib, docetaxel and irinotecan hydrochloride in people with Lung Cancer, run by Northwestern University at 3 sites 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?

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 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00073866, which also lists 1 linked publication.

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 19 Jul 2012; AzTrials last refreshed its copy on 7 Nov 2026.

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