Know Cancer

forgot password

A Phase I Study of Concurrent CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)

Phase 1
18 Years
80 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase I Study of Concurrent CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)

Celecoxib is a non-steroidal-anti-inflammatory drug (NSAIDS), similar to aspirin or
ibuprofen. Recent studies have shown that celecoxib has antitumor activity when used alone.
It may also increase the tumor sensitivity to radiation, making tumors more responsive to
radiation therapy.

Before treatment starts, you will have a complete physical exam, including blood (about 2
teaspoons) and urine tests. You will have a chest x-ray, CT/MRI scans, and/or a PET scan.
You may have a bone scan (x-rays of your bones) if your doctor feels it is necessary. You
may also have blood tests, x-rays, biopsy of the tumor, and any other tests which your
physician feels are necessary for your standard of care.

In this study, you will take celecoxib by mouth for 5 days before beginning radiation
therapy. You will continue to receive celecoxib 7 days per week throughout radiation
treatment (about 7 weeks). The amount of drug that you take will depend on what dose level
you are assigned to. The dose levels are 200mg, 400mg, and 800 mg per day. Ten patients
will be treated on each dose level starting at the lower level. You will be required to
fill out a medication diary, documenting the dose of celecoxib you are taking and the time
that you take it.

You will receive cisplatin and CPT-11 by vein on Day 1 of Weeks 2 through 8. Chemotherapy
will be given on an outpatient basis. CPT-11 will be infused by vein over 90 minutes
followed by cisplatin which will be infused for 60 minutes. Because cisplatin can cause
kidney damage, fluids may need to be injected to "flush" the kidneys. Diuretics are given
by vein just before and after receiving cisplatin. So that the physician may better
evaluate kidney function during this time, you may be asked to save urine specimens and to
keep a record of all fluids taken by mouth during the first 24-48 hours after receiving

Radiation therapy will begin on Day 1 of Week 2 and be given at the same time as
chemotherapy. The radiation therapy treatments will be given once a day for 5 days a week,
Monday-Friday. The total treatment time for individual patients will be decided by the
physician, based on the your general condition and stage of disease. The length of the
radiation treatment should be about 7 weeks (35 radiation treatments).

During treatment, you will have blood tests (about 2 teaspoons) every week. You will report
to your physician the degree of sore throat, difficulty swallowing, gastric burning, or any
symptoms that concern you.

You will be taken off study if the disease becomes worse or side effects become very severe.

After treatment is completed, you will return for follow-up visits at one month, every 3
months for 2 years, every 6 months for 3 to 5 years, then once a year for 10 years. At each
follow-up visit, you will have blood (about 2 teaspoons) samples collected for routine lab
tests and you will have a chest x-ray. You will have a CT scan of the chest every 6 months.
Complete lung function tests will also be done. Lung function tests look at the exchange
of the air flow, capacity of the lung, flexibility of the lung, and exchange of oxygen in
carbon dioxide in the lungs.

This is an investigational study. All of the drugs in this study are FDA approved and
commercially available. The use of these drugs in combination is investigational. Between
30 and 40 patients will take part in this study. All will be enrolled at M. D. Anderson.

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of Celebrex (celecoxib)

Outcome Time Frame:

12 week treatment; Continuous assessment and determination of dose-limiting toxicities.

Safety Issue:


Principal Investigator

Ritsuko R Komaki, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2003

Completion Date:

Related Keywords:

  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Celecoxib
  • Cisplatin
  • Platinol
  • CPT-11
  • Irinotecan
  • SC-58635
  • Celebrex
  • Radiation Therapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030