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Study Summary
No. 2003-0352:.......Lung......Ritsuko R. Komaki......Radiation Oncology
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Study Summary Title
Study Summary
Number:
2003-0352
Study Title:A PHASE I STUDY OF CONCURRENT CPT-11/CISPLATIN AND CELECOXIB WITH RADIATION THERAPY FOR PATIENTS WITH UNRESECTABLE NON-SMALL CELL LUNG CANCER (NSCLC)
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Physician New Patient Referral
Name:Ritsuko R. KomakiPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Radiation OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-2300
Contact us about clinical trials
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General Information
Disease Group:LungSupported By:N/A
Phase of Study:Phase IReturn
Visit:
Follow-up visits every 3 months for 2 yrs, then every 6 months for 3 yrs, then
yearly.
Pet scan should be performed 1 month after completion of chemo and radiation
therapy.
Treatment
Agents:
Celecoxib
Cisplatin
CPT-11
Radiation
Home Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
n/a
Description/
Intervention:
The goal of this clinical research study is to find the highest safe dose of
CELEBREX (celecoxib) that can be given with chemotherapy and radiation therapy
in the treatment of inoperable NSCLC. Researchers want to learn if the
addition of celecoxib to chemotherapy and radiation will make cancer cells more
sensitive to the treatment, thus making radiation more effective in killing
cancer cells. The side effects of this treatment will also be studied.
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Study Objectives / Outcomes
1. To determine feasibility, activity, toxicity of a novel regimen using concurrent Irinotecan/cisplatin and celcoxib combination for patients with unresectable NSCLC.
2. To determine maximal tolerance dose of celecoxib in patients with unresectable NSCLC treated with Irinotecan/cisplatin and concurrent thoracic radiation therapy.
3. To correlate COX-2 expression and other biomarkers with response to the treatment in the tumor from pretreatment biopsy specimen.
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Study Status Information
Study Activation / Registration Date:09/24/2003
IRB Review and Approval Date:06/18/2003
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:36
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) No history of active gastric ulcer, active GI bleeding, or renal failure.

2) Patient must have histological or cytological evidence of NSCLC.

3) Nonresectable Stage II or III NSCLC. Inoperable based on patient's physical status is acceptable.

4) KPS is greater than or equal to 70.

5) Age is greater than or equal to 18 or less than or equal to 80.

6) Patient not receiving irradiation therapy or combined modality therapy to treat another malignancy.

7) No evidence of distant metastatic disease.

8) ANC count (segs & bands) is greater than or equal to 2000/mm3 and platelet count is greater than or equal to 100,000/mm3.

9) Serum creatinine less than or equal to 1.5 mg/dL.

10) Total bilirubin is less than or equal to 1.5 times the institutional upper limits of normal value, SGOT less than or equal to 1.5 times the the institutional upper limit of normal.

11) Patients may not be entered on investigational therapeutic trials.

12) Patients or guardian must be informed of and understand the investigational nature of this study and give written informed consent prior to any study procedures.

13) Patient may have prior chemotherapy. Chemotherapy must have been completed 4 weeks prior to study entry.

14) Patients taking cardio-protective dose of aspirin 81 mg are allowed.

Exclusion Criteria:1) History of poorly controlled hypertension (systolic >150 mm Hg), angina, or other cardiac abnormalities or history of MI or CHF in the last 6 months.

2) General medical or psychological conditions which would not permit the patient to complete the study or sign the informed consent.

3) Pregnancy or women of child bearing potential who do not use an effective (for them) method of birth control throughout their participation in this study.

4) Patients who are currently receiving or have received amifostine for radioprotection within the prior six months are excluded.

5) Patient with history of malignancy other than skin cancer or Carcinoma in-situ within 2 years.

6) Patients who are allergic to Sulfonamides, NSAIDS or Celebrex will be excluded from this protocol.

7) Patients who use routine NSAIDS such as high dose daily use of Aspirin higher than 2 Gm per day will be excluded. Patients will be allowed to take low dose aspirin (less than 200 mg per day).

8) History of cardiovascular diseases that might include one of the following: myocardial infraction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery in the last 6 months.

9) Family history of premature coronary disease (i.e. – onset < 55 years of age).

10) Uncontrolled hypercholesteremia [low-density lipoprotein cholesterol (LDL-C) > 200] more than twice in the repeated tests. Hypercholesteremia needs to be controlled following the updated National Cholesterol Education Program Adult Treatment Panel III Guidelines for at least 3 months prior to enrollment on the study. Hypercholesteremia treatment should continue during the entire period of Celecoxib treatment on the protocol

11) History of deep venous thrombosis, pulmonary embolism, systemic lupus erythematous, family history of protein S or C deficiencies, prior heparin-induced thrombocytopenia, Factor V Leiden deficiencies or high homocysteine levels.

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Links
Registration Number: NCT00346801
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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