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.
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
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
- Being tested
- celecoxib, docetaxel, irinotecan hydrochloride
- 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.
- First posted11 Dec 2003 (estimated)
- Study startJun 2003
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Athanassios Argiris, MD, Study chair, Robert H. Lurie Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial Of Weekly Irinotecan And Docetaxel With The Addition Of Celecoxib In Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00073866
- Acronym / sponsor ID
- NU 01L2
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 11 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celecoxib | Drug | – |
| docetaxel | Drug | – |
| irinotecan hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
- Results publication: PubMed 16096702Argiris 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanassios Argiris, MD study chair
Robert H. Lurie Cancer Center
3 sites in 1 country: see every site and its status.
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.