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Lung CancerPhase 2NCT00030407

Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

A Phase 2 study testing Celecoxib and Docetaxel in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute 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

RATIONALE: Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy and celecoxib 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 and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
Oct 2001to Apr 2009
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

DISEASE CHARACTERISTICS:

  • Diagnosis of non-small cell lung cancer (NSCLC)
  • Stage IIIB with pleural effusion or stage IV disease
  • Age 70 years and over with SWOG performance status 0-2 OR age 18 to 69 with SWOG performance status 2
  • Measurable or evaluable disease
  • No symptomatic or untreated brain or leptomeningeal metastases
  • Previously treated patients must be neurologically stable for 4 weeks after completion of appropriate therapy

PATIENT CHARACTERISTICS:

Age:

  • See Disease Characteristics
  • 18 and over

Performance status:

  • See Disease Characteristics
  • SWOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 8 g/dL

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST/ALT no greater than ULN (or no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN)
  • Alkaline phosphatase no greater than ULN (or no greater than 5 times ULN if AST/ALT no greater than ULN)
  • No history of chronic hepatitis

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No uncontrolled congestive heart failure
  • No uncontrolled angina
  • No myocardial infarction and/or stroke within the past 6 months
  • No active thromboembolic event within the past 4 weeks

Gastrointestinal:

  • No gastrointestinal bleeding within the past 6 months
  • No history of peptic ulcer disease

Other:

  • No prior hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No prior allergy to any non-steroidal anti-inflammatory drug
  • No other prior or concurrent malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
  • No grade 2 or greater peripheral neuropathy
  • No other serious concurrent medical illness
  • No history of dementia, active psychiatric disorder, or other condition that would interfere with ability to take oral medication or preclude compliance with study
  • HIV negative
  • Must weigh at least 50 kg (110 pounds)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy for NSCLC

Chemotherapy:

  • No prior chemotherapy for NSCLC

Endocrine therapy:

  • At least 3 days since prior steroids

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to target lesion

Surgery:

  • At least 4 weeks since prior major surgery

Other:

  • Prior intermittent use of non-steroidal anti-inflammatory drugs (NSAIDs), including rofecoxib or celecoxib, allowed
  • At least 1 week since prior fluconazole
  • No recent prior NSAIDs, including rofecoxib or celecoxib, for a duration of more than 30 consecutive days
  • No concurrent fluconazole or lithium
  • No concurrent NSAIDs except aspirin administered at a dose of no more than 325 mg/day for cardiovascular conditions
  • No other concurrent cyclo-oxygenase-2 inhibitors
  • No other concurrent investigational agents

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

Other trials in United States

About this study

Official title: Evaluation Of Celecoxib In Combination With Weekly Docetaxel In Elderly (70 Years) Or Poor Performance Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

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

PURPOSE: Phase II trial to study the effectiveness of celecoxib and docetaxel in treating patients who have non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

  • Determine the efficacy and feasibility of celecoxib combined with docetaxel as first-line therapy in elderly or poor performance status patients with advanced non-small cell lung cancer.
  • Determine the response rate of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral celecoxib twice daily (beginning on day -7 of the first course) and docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses after CR. Patients who achieve stable disease (SD) or a partial response (PR) receive a minimum of 2 additional courses after SD or PR. At the discretion of the treating physician, patients then receive maintenance therapy comprising celecoxib only.

Patients who discontinue therapy for disease progression or unacceptable toxicity are followed for at least 6 months.

PROJECTED ACCRUAL: A total of 21-39 patients will be accrued for this study within 13-28 months.

Conditions
Lung Cancer
Being tested
Celecoxib, Docetaxel
Keywords
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.

  • CelecoxibDrug

    Also called Celebrex, Celebra

    On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals

  • DocetaxelDrug

    Also called Taxotere®

    On day 1, 8, and 15 of each cycle patients will receive: Docetaxel 36mg/m2 over 60 minutes, duration of each cycle will be 28 days.

Study groups in NCT00030407
Study groupRoleWhat they receive
Celecoxib & DocetaxelExperimentalCelecoxib: On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals Docetaxel: On day 1, 8, and 15 of each cycle patients will receive: Docetaxel 36mg/m2 over 60 minutes, duration of each cycle will be 28 days.
Receives: Drug: Celecoxib; Drug: Docetaxel

What is being measured

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

  1. Efficacy of combining celecoxib with docetaxel in elderly (> or = 70 yrs old) or poor performance status (PS)of 2

    Blood levels of VEGF \& PGE2

    Measured: Weeks 1, 2, and 3

Secondary outcomes (4)

  1. Response rate of Celecoxib and Docetaxel

    CT Chest/Abdomen

    Measured: Every 2 cycles (or every 42 days); After therapy is completed or if the patient is only on Celecosxib, will be assessed for progression every month by clinical exam and every 3 months by radiological evaluation.

  2. Toxicity of Celecoxib and Docetaxel

    Routine bloodwork

    Measured: Weeks 1, 2, and 3 of each 28 day cycle

  3. Expression of cyclooxygenase-2 (COX-2) in tumors

    Tissue sample from initial diagnosis, parrafin embedded tissue block

    Measured: Pre-Study

  4. Changes in plasma levels of prostaglandin E2(PGE2) & vascular endothelial growth factor (VEGF)

    Collecting blood plasma

    Measured: Pre-study, Weeks 1, 2 and 5

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2001
  3. Primary completionSep 2005
  4. Study completionApr 2009

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00030407
Sponsor's protocol ID
CDR0000069163
Other IDs
P30CA022453, WSU-C-2305, NCI-V01-1687
Status last verified
Apr 2013
First submitted
14 Feb 2002
Last updated
29 Apr 2013
Results posted
No
Data monitoring committee
No

Publications

  • Gadgeel SM, Wozniak A, Ruckdeschel JC, Heilbrun LK, Venkatramanamoorthy R, Chaplen RA, Kraut MJ, Kalemkerian GP. Phase II study of docetaxel and celecoxib, a cyclooxygenase-2 inhibitor, in elderly or poor performance status (PS2) patients with advanced non-small cell lung cancer. J Thorac Oncol. 2008 Nov;3(11):1293-300. doi: 10.1097/JTO.0b013e31818b194e.

    PubMed 18978565

  • Gadgeel SM, Shehadeh N, Kraut MJ, et al.: Preliminary results of a phase II study of celecoxib and weekly docetaxel in elderly (>70 yrs) or PS2 patients with advanced non-small cell lung cancer (NSCLC). [Abstract] Lung Cancer 41 (Suppl 2): A-O-110, S35, 2003.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Celecoxib and Docetaxel in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute 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?

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 29 Apr 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?

Efficacy of combining celecoxib with docetaxel in elderly (> or = 70 yrs old) or poor performance status (PS)of 2 (time frame: Weeks 1, 2, and 3). 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 NCT00030407, which also lists 2 linked publications.

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 29 Apr 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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