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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00030420
Recruitment Status : Completed
First Posted : October 21, 2003
Last Update Posted : April 29, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Tracking Information
First Submitted Date  ICMJE February 14, 2002
First Posted Date  ICMJE October 21, 2003
Last Update Posted Date April 29, 2013
Study Start Date  ICMJE October 2001
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2013)
Efficacy of combining Celecoxib with Docetaxel [ Time Frame: Weeks 1 , 2 and 3 ]
Blood levels of VEGF & PGE2
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2013)
  • Response rate of Celecoxib and Docetaxel [ Time Frame: Every 2 cycles (or every 42 days); After therapy is completed or if the patient is only on Celecoxib, will be assessed for progression every month by clinical exam and every 3 months by radiological evaluation. ]
    CT Chest/Abdomen
  • Toxicity of Celecoxib and Docetaxel [ Time Frame: Every week ]
    Routine bloodwork
  • Expression of cyclooxygenase-2 (COX-2) in tumors [ Time Frame: Pre-study ]
    Tissue sample from initial diagnosis, parrafin embedded tissue block
  • Changes in plasma levels of prostaglandin E2 (PGE2) & vascular endthelial growth factor (VEGF) [ Time Frame: Pre-study; Weeks 1 , 2 and 3 ]
    Collecting blood plasma
  • Vascular changes induced in the tumor by celecoxib [ Time Frame: Weeks 1, 3 & 6 ]
    Using DCE-MRI and PET scans to evaluate.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE Evaluation Of Celecoxib In Combination With Docetaxel In The Treatment Of Advanced Non-Small Cell Lung Cancer Patients Previously Treated With Platinum Based Chemotherapy
Brief 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 with celecoxib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and docetaxel in treating patients who have advanced non-small cell lung cancer that has been previously treated with platinum-based chemotherapy.

Detailed Description

OBJECTIVES:

  • Determine the efficacy and feasibility of celecoxib combined with docetaxel in patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy.
  • 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 day 1. Treatment repeats every 21 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: Celecoxib
    400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment.
    Other Names:
    • Celebrex
    • Celebra
    • Onsenal
  • Drug: Docetaxel
    On day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days
    Other Name: Taxotere
Study Arms  ICMJE Experimental: Celecoxib & Docetaxel

Celecoxib: 400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment.

Doctaxel: Day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days

Interventions:
  • Drug: Celecoxib
  • Drug: Docetaxel
Publications * Schneider BJ, Kalemkerian GP, Kraut MJ, Wozniak AJ, Worden FP, Smith DW, Chen W, Gadgeel SM. Phase II study of celecoxib and docetaxel in non-small cell lung cancer (NSCLC) patients with progression after platinum-based therapy. J Thorac Oncol. 2008 Dec;3(12):1454-9. doi: 10.1097/JTO.0b013e31818de1d2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2013)
24
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Diagnosis of stage IIIA, IIIB, or IV non-small cell lung cancer

    • Disease progression during or after 1 or more platinum-based chemotherapy regimens
  • 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:

  • 18 and over

Performance status:

  • 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 of any duration

Renal:

  • Creatinine no greater than 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 active infection
  • 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:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • Prior paclitaxel allowed
  • No prior docetaxel

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 other 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00030420
Other Study ID Numbers  ICMJE CDR0000069164
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-C-2304 ( Other Identifier: Barbara Ann Karmanos Cancer Institute )
NCI-V01-1688
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barbara Ann Karmanos Cancer Institute
Study Sponsor  ICMJE Barbara Ann Karmanos Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Shirish M. Gadgeel, MD Barbara Ann Karmanos Cancer Institute
PRS Account Barbara Ann Karmanos Cancer Institute
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP