Celecoxib as Adjuvant Biologic Therapy in Patients With Head and Neck and Lung Cancer
Information source: M.D. Anderson Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer; Lung Cancer
Intervention: Celecoxib (Drug); No Treatment (Other)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: M.D. Anderson Cancer Center
Official(s) and/or principal investigator(s):
Waun K. Hong, MD, Principal Investigator, Affiliation: U.T.M.D. Anderson Cancer Center
1. To examine the effect of celecoxib treatment on histological response (defined in
Appendix H), 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 HNSCC or NSCLC.
Official title: Celecoxib as Adjuvant Biologic Therapy in Patients With Early Stage Head and Neck and Lung Cancer
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The goal of this clinical research study is to look at what effects the drug celecoxib (Celebrex™) has on the blood and tissues of patients who have previously been treated for early stage NSCLC or HNSCC.
Secondary outcome: The side effects of celecoxib will also be studied.
In order to enroll in this trial, you must also be enrolled in Protocol 2003-0424. The study
procedures and tests that are part of this study are the same procedures and tests that are
part of Protocol 2003-0424. Even though a procedure or test is described in both this
consent and the consent for Protocol 2003-0424, you will only have the described procedure or
test done once. For example, both this study and Protocol 2003-0424 require a complete
physical exam before beginning treatment. In this case, you will only have one physical exam
that will count for both studies.
Celecoxib is a drug that slows the production of chemicals in the body that cause
inflammation. Celecoxib works by interfering with the action of the chemical cyclooxygenase,
a chemical that is involved in inflammation. It is believed that the product of chemicals
that cause inflammation may be involved in cancer development.
Before treatment starts, you will have a complete physical exam, including measurement of
height, weight, blood pressure, and vital signs. You will have blood samples drawn for
routine blood tests (about 3 teaspoons) and for research purposes (about 4 teaspoons) .
Women who are able to have children must have a negative pregnancy test (blood or urine).
You will also have a chest x-ray and a CT scan of your chest.
You will also have a bronchoscopy (tissue sample from the lung) at the beginning of this
study for lab analysis. For this procedure, you will be given drugs to relax. Then, a local
anesthetic will be sprayed in your nose and throat to numb those areas. A slim, flexible
tube with a light will be placed through your nose or mouth and into your lungs. Tweezers
will be fed through the tube to collect lung tissue (biopsy) samples from 6 different places
in your lungs. During the bronchoscopy procedure, a complete inspection of the airways will
be performed. Any suspicious areas that are seen under the white-light and autofluorescence
bronchoscopy will be identified and more biopsies and brushings will be performed to evaluate
whether any pre-cancerous tissue is present. You will also have a bronchial brushing next to
each biopsy site. In a bronchial brushing, a small brush is fed through the tube into your
lungs and a sample of lung tissue is gently scraped off. When the biopsies and brushings are
done, you will have a bronchial lavage (bronchial washing). In the bronchial lavage, a small
amount of water (about 4 tablespoons) is sprayed into your lungs and then suctioned out
through the tube. This fluid is used to collect additional tissue and mucous samples. In
addition, a sputum (saliva) sample will be taken and the inside of your cheek will be scraped
If you have had HNSCC, you will also have a laryngoscopy. In a laryngoscopy, a lighted tube
is placed down your throat and the larynx is checked. The back of your throat will be
sprayed with an anesthetic before this procedure to make the procedure more comfortable.
In this study you will be randomly assigned (as in the toss of a coin) to one of two groups.
Participants in one group will receive celecoxib. Participants in the other group will
receive no treatment. Current standard practice for individuals who have had therapy for
early stage NSCLC or HNSCC is follow-up (no treatment). You have a 2 to 1 chance of being
assigned to the treatment group. That means that 2 out of every 3 participants in this study
will be assigned to the treatment group.
If you are assigned to the treatment group you will take celecoxib by mouth in two divided
doses at least 8 hours apart every day. Your study doctor will tell you exactly how many
pills you should take each day. You will take celecoxib for up to 12 months. You will be
taken off study if intolerable side effects occur or if the disease comes back.
If you are assigned to the treatment (celecoxib) group, you will have a physical exam by a
physician or nurse at months 3, 6, and 12 for the first year of treatment. If you are
assigned to the "no treatment" group, the nurse will contact you by phone every 3 months for
the first year on this study to see how you are doing and you will have a physical exam by
either a physician or a nurse every 6 months. During the first year, all participants will
have blood samples taken at each clinic visit for routine blood tests (about 3 teaspoons) and
for research purposes (about 4 teaspoons). In addition, all participants will have a chest
x-ray and chest CT at months 6 and 12. All participants will also have a bronchoscopy and
provide sputum, saliva, and buccal smear samples at 12 months. If you have been treated for
HNSCC, you will have a laryngoscopy at 12 months.
After the first year, you will be followed for a minimum of 2 more years and a maximum of 6
years. You will have physical exams at 24 and 36 months. You will have blood draws (about
3 teaspoons for routine tests and 4 teaspoons for research purposes), a chest x-ray and a
chest CT at 18, 24, 30 and 36 months. After 36 months, you will have a physical exam by a
physician or nurse every 6 months for up to 6 years. Every 12 months the physical exam will
be done by a physician. The other physical exams will be done by a nurse. You will have
blood drawn for routine tests (about 3 teaspoons) and research purposes (about 4 teaspoons)
every 12 months.
This research study includes two bronchoscopies done one year apart. These bronchoscopies
are being done primarily for research purposes and are unlikely to provide information useful
in your individual treatment. These bronchoscopies do have risks associated with them.
These risks are described in section 4 of this informed consent document.
Recent research on early stage NSCLC indicates that adjuvant chemotherapy after surgery
increases the length of time a person may survive and the length of time before cancer
recurs. However, this adjuvant chemotherapy also has side effects that can be severe and in
rare cases fatal. If you have had surgery for NSCLC and wish to receive adjuvant
chemotherapy, you may only enroll in this study and Protocol 2003-0424 after you have
completed the adjuvant chemotherapy.
As part of this study you will provide samples of your lung tissue, saliva, blood, and
scrapings from the inside of your cheek. Fluid and mucous collected during the
bronchoscopies will also collected. These samples will be studied by scientists to learn
about genes and proteins in people who have been treated for early NSCLC or HNSCC. The
samples will also be used to grow cells and cultures that will be used to test chemotherapy
drugs. These cells and cultures will also be used to learn about genes and proteins.
All MDACC researchers are trained in the importance of maintaining patient privacy. Your
privacy will be protected by assigning you a number that will be used in place of your name
on documents that are part of this study. A list that links your name with your study number
will be stored in a restricted file that may be accessed only with a password. Only a few
essential research personnel have access to this password.
At the end of the study you will not be automatically notified of the research findings. If
you wish to learn about the results, however, you may request them from the principal
Principal Investigator: Waun Ki Hong, MD 1515 Holcombe Blvd., Unit 432 MD Anderson Cancer
Center Houston, TX 77030
This is an investigational study. Celecoxib is a commonly used drug that is approved by the
FDA for treatment of arthritis, colon polyps, and pain. The use of celecoxib to help prevent
cancer is approved by the FDA for research only. Celecoxib will be provided free of charge
during the study. All procedures that are required by this study and not covered by third
party insurance will be paid for by this study. A total of up to 70 individuals will take
part in this multicenter study. Up to 50 will be enrolled at UTMDACC.
This protocol is partially funded by a research grant from the US Department of Defense
Minimum age: 18 Years.
Maximum age: N/A.
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
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
13. Participant must be enrolled in MDACC 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.
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
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 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.
Locations and Contacts
U.T.M.D. Anderson Cancer Center, Houston, Texas 77030, United States
Starting date: September 2005
Last updated: February 26, 2008