Lung CancerPhase 1NCT00346801
CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study testing Celecoxib, Cisplatin and CPT-11 in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: To determine the feasibility, activity, and toxicity of a novel regimen using a concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with unresectable NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Celecoxib, Cisplatin and CPT-11
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Oct 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No history of active gastric ulcer, active GI bleeding, or renal failure.
- Patient must have histological or cytological evidence of NSCLC.
- Nonresectable Stage II or III NSCLC. Inoperable based on patient's physical status is acceptable.
- KPS is greater than or equal to 70.
- Age is greater than or equal to 18 or less than or equal to 80.
- Patient not receiving irradiation therapy or combined modality therapy to treat another malignancy.
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- No evidence of distant metastatic disease.
- ANC count (segs \& bands) is greater than or equal to 2000/mm3 and platelet count is greater than or equal to 100,000/mm3.
- Serum creatinine less than or equal to 1.5 mg/dL.
- 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.
- Patients may not be entered on investigational therapeutic trials.
- 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.
- Patient may have prior chemotherapy. Chemotherapy must have been completed 4 weeks prior to study entry.
- Patients taking cardio-protective dose of aspirin 81 mg are allowed.
Who cannot join
- 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.
- General medical or psychological conditions which would not permit the patient to complete the study or sign the informed consent.
- 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.
- Patients who are currently receiving or have received amifostine for radioprotection within the prior six months are excluded.
- Patient with history of malignancy other than skin cancer or Carcinoma in-situ within 2 years.
- Patients who are allergic to Sulfonamides, NSAIDS or Celebrex will be excluded from this protocol.
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- 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).
- 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.
- Family history of premature coronary disease (i.e. - onset < 55 years of age).
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
Primary Objectives:
- To determine the feasibility, activity, and toxicity of a novel regimen using a concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with unresectable NSCLC.
- To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC treated with irinotecan/cisplatin and concurrent thoracic radiation therapy.
- To correlate the COX-2 expression and other biomarkers with response to the treatment in the tumor from a pretreatment biopsy specimen.
Read the detailed description
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 cisplatin.
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.
- Conditions
- Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Lung Cancer, Celecoxib, Cisplatin, Platinol, CPT-11, Irinotecan, SC-58635, Celebrex, Radiation Therapy
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex, SC-58635
100 mg by mouth (PO) twice daily for 5 days before beginning radiation therapy; continued 7 days per week throughout radiation treatment (about 7 weeks).
CisplatinDrug
Also called Platinol-AQ, Platinol, CDDP
25 mg/m^2 IV over 60 minutes on Day 1, Weeks 2-8
CPT-11Drug
Also called Irinotecan
30 mg/m^2 IV over 90 minutes on Day 1, Weeks 2-8, followed by cisplatin which will be infused for 60 minutes.
Concurrent Thoracic Radiation TherapyRadiation
Also called XRT, RT
63 Gy at 1.8 Gy/Fx in 35 Fractions over 7 weeks starting 2nd week of celebrex.
| Study group | Role | What they receive |
|---|---|---|
| CPT-11 + Celecoxib/Cisplatin with RT | Experimental | CPT-11 + Celecoxib + Cisplatin + Radiation Therapy (RT) Receives: Drug: Celecoxib; Drug: Cisplatin; Drug: CPT-11; Radiation: Concurrent Thoracic Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Celebrex (celecoxib)
Measured: 12 week treatment; Continuous assessment and determination of dose-limiting toxicities.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2006 (estimated)
- Study startSep 2003
- Primary completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Ritsuko R Komaki, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346801
- Sponsor's protocol ID
- 2003-0352
- Status last verified
- Oct 2012
- First submitted
- 28 Jun 2006
- Last updated
- 22 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT00346801
- Acronym / sponsor ID
- 2003-0352
- Conditions
- Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Lung Cancer, Celecoxib, Cisplatin, Platinol, CPT-11, Irinotecan, SC-58635
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- Sep 2003
- Primary completion
- Oct 2012 (actual)
- First posted
- 30 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- To determine the feasibility, activity, and toxicity of a novel regimen using a concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with unresectable NSCLC.
- To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC treated with irinotecan/cisplatin and concurrent thoracic radiation therapy.
- To correlate the COX-2 expression and other biomarkers with response to the treatment in the tumor from a pretreatment biopsy specimen.
Detailed description
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 cisplatin.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPT-11 + Celecoxib/Cisplatin with RT | Experimental | Drug: Celecoxib, Drug: Cisplatin, Drug: CPT-11, Radiation: Concurrent Thoracic Radiation TherapyCPT-11 + Celecoxib + Cisplatin + Radiation Therapy (RT) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- No history of active gastric ulcer, active GI bleeding, or renal failure.
- Patient must have histological or cytological evidence of NSCLC.
- Nonresectable Stage II or III NSCLC. Inoperable based on patient's physical status is acceptable.
- KPS is greater than or equal to 70.
- Age is greater than or equal to 18 or less than or equal to 80.
Key exclusion criteria (11 listed)
- 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.
- General medical or psychological conditions which would not permit the patient to complete the study or sign the informed consent.
- 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.
- Patients who are currently receiving or have received amifostine for radioprotection within the prior six months are excluded.
- Patient with history of malignancy other than skin cancer or Carcinoma in-situ within 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelecoxibAlso: Celebrex, SC-58635100 mg by mouth (PO) twice daily for 5 days before beginning radiation therapy; continued 7 days per week throughout radiation treatment (about 7 weeks). | Drug | CPT-11 + Celecoxib/Cisplatin with RT |
| CisplatinAlso: Platinol-AQ, Platinol, CDDP25 mg/m^2 IV over 60 minutes on Day 1, Weeks 2-8 | Drug | CPT-11 + Celecoxib/Cisplatin with RT |
| CPT-11Also: Irinotecan30 mg/m^2 IV over 90 minutes on Day 1, Weeks 2-8, followed by cisplatin which will be infused for 60 minutes. | Drug | CPT-11 + Celecoxib/Cisplatin with RT |
| Concurrent Thoracic Radiation TherapyAlso: XRT, RT63 Gy at 1.8 Gy/Fx in 35 Fractions over 7 weeks starting 2nd week of celebrex. | Radiation | CPT-11 + Celecoxib/Cisplatin with RT |
Primary outcome
Maximum Tolerated Dose (MTD) of Celebrex (celecoxib)
Time frame: 12 week treatment; Continuous assessment and determination of dose-limiting toxicities.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2012.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ritsuko R Komaki, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Celecoxib, Cisplatin and CPT-11 in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Celebrex (celecoxib) (time frame: 12 week treatment; Continuous assessment and determination of dose-limiting toxicities.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2012.