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Celecoxib as Adjuvant Biologic Therapy in Patients With Head and Neck and 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. Identifier: NCT00527982
Recruitment Status : Terminated (Termination due to poor accrual.)
First Posted : September 11, 2007
Results First Posted : April 20, 2011
Last Update Posted : December 6, 2012
United States Department of Defense
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Primary Objectives:

  1. To examine the effect of celecoxib treatment on histological response, markers of proliferation (Ki-67), and apoptosis. Secondary endpoints include time to second primary or recurrence and survival.
  2. To examine the toxicity associated with celecoxib administration in patients with previously treated Head and Neck Head and neck squamous cell carcinomas (HNSCC)or Non-small-cell lung carcinoma (NSCLC).

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Lung Cancer Drug: Celecoxib Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Celecoxib as Adjuvant Biologic Therapy in Patients With Early Stage Head and Neck and Lung Cancer
Study Start Date : September 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Celecoxib treatment
600 mg orally (PO) daily
Drug: Celecoxib
600 mg by mouth daily for a total of 12 months.
Other Name: Celebrex

No Intervention: No treatment

Primary Outcome Measures :
  1. Histological Responses [ Time Frame: Baseline to 12 months ]
    Number of patients with histological response based on changes in bronchoscopies from baseline to 12 months.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with either: a) histologically proven stage I, II, or IIIa NSCLC who have undergone a complete surgical resection of the primary tumor OR b) stage I or II HNSCC who have undergone definitive local treatment (surgery or radiation therapy).
  2. HNSCC patients: Definitive local treatment </= 12 months prior to trial enrollment. NSCLC patients: Surgery </= 12 months prior to trial enrollment.
  3. No evidence residual cancer
  4. Smoking history of at least 10 pack years. May be current or former smoker.
  5. Performance status of < = 2 (Zubrod)
  6. Age =>18 years
  7. Participants must have no contraindications for undergoing bronchoscopy.
  8. Patients must have no active pulmonary infections.
  9. Participants must not be taking oral non-steroidal anti-inflammatory drugs on a regular basis.
  10. Participants must have the following blood levels: total granulocyte count >1500; platelet count > 100,000; total bilirubin < = 1.5 mg. %; and creatinine < = 1.5 mg %.
  11. Participants must complete the pretreatment evaluation and must consent to bronchoscopy and to endobronchial biopsy for biomarker studies.
  12. All subjects who agree to participate will be given a written and verbal explanation of the study requirements and a consent form that must be signed prior to registration. Subjects will be informed that (a) they must be willing to take capsules daily for the duration of the trial, (b) they must be willing to take biopsies through bronchoscopy and give blood samples at the specified times, (c) they must schedule and keep the specified follow-up visits with their physicians and the study clinics, and (d) side effects and health risks may occur, as described in the informed consent form.
  13. Participant must be enrolled in UT MD Anderson Cancer Center protocol #2003-0424 titled "A Phase IIb Vanguard Study Characterizing the Occurrence of Recurrent or Second Primary Tumors in Patients with a Prior History of a Definitively Treated Stage I/II Head and Neck or Non-Small Cell Cancer who are Current or Former Smokers."
  14. Patients with prior head and neck cancer only: Participants must have no contraindications for undergoing laryngoscopy.
  15. Subject must be considered legally capable of providing his or her own consent for participation in this trial.

Exclusion Criteria:

  1. History of radiation therapy to the chest. For those patients with head and neck cancer who received radiation, no more than 10% of the lung volume (apices) may be included.
  2. History of systemic chemotherapy. Exception: NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy.
  3. Pregnant or breast-feeding (a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required)
  4. Participants with active gastric or duodenal ulcers or a history of ulcers requiring prophylactic H2 blockers.
  5. Participants with active pulmonary infections or recent history of pulmonary infection (within one month).
  6. Participants with acute intercurrent illness
  7. Participants requiring chronic ongoing treatment with Nonsteroidal anti-inflammatory drugs (NSAIDs). (Casual or non-prescribed use of NSAIDs is permitted as long as their use does not exceed one week at a time.)
  8. Participants who are allergic to aspirin or sulfanamides.
  9. Patients may not take high dose antioxidants (vitamins E or C) during the study period. "High dose" will be determined by the study investigators.
  10. Patients may not take high dose synthetic or natural Vitamin A derivatives (> 10,000 IU per day).
  11. History of biologic therapy
  12. Women of childbearing potential and men with partners of childbearing potential who are not using an effective method of contraception. Use of contraception will be verified at office visits during first year on study.
  13. History of cardiovascular diseases that might include one of the following: myocardial infarction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery.
  14. Diagnosis of diabetes
  15. History of deep venous thrombosis, pulmonary embolism, systemic lupus erythematosus, family history of protein S or C deficiencies, prior heparin-induced thrombocytopenia, or known Factor V Leiden mutation.
  16. Family history of premature CAD. This is defined as individuals with either: 1) father with MI prior to age 55, or 2) mother with MI prior to age 60.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00527982

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United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
United States Department of Defense
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Principal Investigator: Waun K. Hong, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00527982     History of Changes
Other Study ID Numbers: 2004-0104
First Posted: September 11, 2007    Key Record Dates
Results First Posted: April 20, 2011
Last Update Posted: December 6, 2012
Last Verified: December 2012
Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Lung Cancer
Non-Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Head and Neck Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action