Celecoxib as Adjuvant Biologic Therapy in Patients With Head and Neck and Lung Cancer
Condition: Head and Neck Cancer; Lung Cancer
MeSH terms: Lung Neoplasms; Head and Neck Neoplasms
Intervention: Celecoxib
Intervention description: 600 mg by mouth daily for a total of 12 months.
Intervention MeSH terms: Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and Neck Cancer; Lung Cancer; Non-Small Cell Lung Cancer; Celecoxib; Celebrex

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).
    

Eligibility criteria:

        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.