Celecoxib as Adjuvant Biologic Therapy in Patients With Head and Neck and Lung Cancer

NCT00527982 | Terminated Phase 2 Results

• 1 other identifier: 2004-0104
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 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. 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).

Conditions

Head and Neck Cancer; Lung Cancer

Keywords

Head and Neck Cancer; Lung Cancer; Non-Small Cell Lung Cancer; Celecoxib; Celebrex

Outcome Measures

Primary Outcomes (1)

• Histological Responses

  Number of patients with histological response based on changes in bronchoscopies from baseline to 12 months.

  Baseline to 12 months

Study Arms (2)

Celecoxib treatment

EXPERIMENTAL

600 mg orally (PO) daily

Drug: Celecoxib

No treatment

NO INTERVENTION

Interventions

Celecoxib DRUG

600 mg by mouth daily for a total of 12 months.

Also known as: Celebrex

Celecoxib treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• HNSCC patients: Definitive local treatment \</= 12 months prior to trial enrollment. NSCLC patients: Surgery \</= 12 months prior to trial enrollment.
• No evidence residual cancer
• Smoking history of at least 10 pack years. May be current or former smoker.
• Performance status of \< = 2 (Zubrod)
• Age =\>18 years
• Participants must have no contraindications for undergoing bronchoscopy.
• Patients must have no active pulmonary infections.
• Participants must not be taking oral non-steroidal anti-inflammatory drugs on a regular basis.
• 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 %.
• Participants must complete the pretreatment evaluation and must consent to bronchoscopy and to endobronchial biopsy for biomarker studies.
• 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.
• 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."
• Patients with prior head and neck cancer only: Participants must have no contraindications for undergoing laryngoscopy.
• Subject must be considered legally capable of providing his or her own consent for participation in this trial.

You may not qualify if:

• 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.
• History of systemic chemotherapy. Exception: NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy.
• Pregnant or breast-feeding (a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required)
• Participants with active gastric or duodenal ulcers or a history of ulcers requiring prophylactic H2 blockers.
• Participants with active pulmonary infections or recent history of pulmonary infection (within one month).
• Participants with acute intercurrent illness
• 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.)
• Participants who are allergic to aspirin or sulfanamides.
• Patients may not take high dose antioxidants (vitamins E or C) during the study period. "High dose" will be determined by the study investigators.
• Patients may not take high dose synthetic or natural Vitamin A derivatives (\> 10,000 IU per day).
• History of biologic therapy
• 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.
• History of cardiovascular diseases that might include one of the following: myocardial infarction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery.
• Diagnosis of diabetes
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Head and Neck Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Waun K. Hong, MD/Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Waun K. Hong, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 11, 2007
• Study Start: September 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 6, 2012
• Results First Posted: April 20, 2011

Record last verified: 2012-12

Locations

US (1)