Lung CancerPhase 2NCT00062179
Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
A Phase 2 study testing carboplatin, celecoxib and paclitaxel in people with Lung Cancer, run by Jonsson Comprehensive Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy such as paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug, may stop the growth of tumor cells by stopping… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- carboplatin, celecoxib and paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2003to Nov 2006
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biopsy proven non-small cell lung cancer clinical stage IIIA
- Mediastinoscopy positive N2 disease is mandatory
- The disease must be deemed potentially resectable by the thoracic surgeon
- Karnofsky performance status > 80%
- Pulmonary function must be acceptable for surgery according to institutional standards
- Acceptable hepatic, renal and bone marrow function
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- Total serum bilirubin < ULN
- AST and/or ALT < 2.5x ULN
- Alkaline phosphatase < 2.5x ULN
- Serum creatinine < 2.0 mg/mm3
- White blood cell > 3000/mm3
- Platelets > 100,000/mm3
- Age 18 or older
- Willingness to abstain from chronic use of NSAIDs (defined as > 7 days of continuous therapy per month OR defined as frequency of > 3 times per week) for the duration of the study. For those patients on NSAIDs prior to study entry, cessation of the drug for 72 hours prior to study entry is required
- Patients on low-dose ASA (<325 mg daily) for prophylaxis of cardiovascular disease prior to study entry may remain on that dose of ASA during this trial
- No anticipated chronic use of steroids. Patients may take the inhaled steroids mometasone or fluticasone if medically indicated
Who cannot join
- Patients with known hypersensitivity or allergic reactions to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates
- Hypersensitivity to paclitaxel
- Significant medical or psychiatric illness that would interfere with patient compliance
- Prior malignancy within the last 3 years with the exception of non-melanoma skin cancer
- Receiving other investigational agents during the course of this study or are < 3 weeks from completion of other clinical trial therapy
- Patients with a history of peptic ulcer disease, bleed disorder, irritable bowel disease, inflammatory bowel syndrome, chronic diarrhea or bowel obstruction within 5 years
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- Patients receiving enzyme-inducing anticonvulsants are ineligible. Patients who require concomitant therapy with NSAIDs or COX-2 inhibitors
- Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment
- Patients receiving lithium or fluconazole
- Pregnant women or women of childbearing potential that refuse to use effective contraception during the period of chemotherapy.
- Patients with a significant history of unstable cardiovascular disease
- Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021
About this study
Official title: A Randomized Double Blind Phase II Study of Preoperative Celecoxib/Paclitaxel/Carboplatin for Stage IIIA Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy such as paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug, may stop the growth of tumor cells by stopping blood flow to the tumor, and/or may block the enzymes necessary for tumor cell growth. Giving combination chemotherapy with celecoxib before surgery may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving paclitaxel together with carboplatin followed by surgery works compared to giving paclitaxel together with carboplatin and celecoxib followed by surgery in treating patients with stage IIIA non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Compare the complete pathological response rate and/or minimal residual microscopic disease in patients with stage IIIA non-small cell lung cancer treated with preoperative paclitaxel and carboplatin with vs without celecoxib.
- Compare the clinical response rate in patients treated with these regimens.
- Compare chemotherapy-related toxicity in patients treated with these regimens.
- Compare the time to progression, disease-free survival, and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to use of aspirin for prior cardiovascular disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1, 22, and 43. Patients also receive oral celecoxib twice daily beginning on day 1 and continuing until the morning of surgical resection.
- Arm II: Patients receive paclitaxel and carboplatin as in arm I and an oral placebo twice daily beginning on day 1 and continuing until the morning of surgical resection.
In both arms, patients undergo surgical resection and complete mediastinal lymph node dissection within 3-6 weeks after completion of chemotherapy. Patients resume oral celecoxib or placebo twice daily within 28-42 days after surgery and continue until 3 years from the date of randomization in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3-6 months.
PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- carboplatin, celecoxib, paclitaxel, Placebo
- Keywords
- stage IIIA non-small cell lung cancer
- 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.
carboplatinDrug
Carboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apart
celecoxibDrug
Celecoxib: 400 mg po BID celecoxib 3-7 days before first dose of chemotherapy
paclitaxelDrug
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apart
PlaceboOther
placebo 3-7 days before first dose of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel/carboplatin/celecoxib | Experimental | Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion Carboplatin: dosed at an AUC of 6 by the Calvert Formula Celecoxib: 400 mg po BID 3 cycles of paclitaxel and carboplatin 21 days apart celecoxib 3-7 days before first dose of chemotherapy Receives: Drug: carboplatin; Drug: celecoxib; Drug: paclitaxel |
| paclitaxel/Carboplatin/Placebo | Placebo comparator | Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion Carboplatin: dosed at an AUC of 6 by the Calvert Formula Placebo 3 cycles of paclitaxel and carboplatin 21 days apart Placebo 3-7 days before first dose of chemotherapy Receives: Drug: carboplatin; Drug: paclitaxel; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of complete pathological response and/or minimal residual microscopic disease at 3 years
Measured: 3 years
Secondary outcomes (3)
Clinical response at 3 years
Measured: 3 years
Difference in time to progression, disease-free survival, and overall survival between Arm I and Arm II at 3 years
Measured: 3 years
Toxicity in patients with paclitaxel/carboplatin/celecoxib vs. paclitaxel/carboplatin/placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2003 (estimated)
- Study startMar 2003
- Primary completionNov 2006
- Study completionNov 2006
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 Jonsson Comprehensive 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacia
- Responsible party
- Sponsor
- Investigators
- Karen Rickard, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062179
- Sponsor's protocol ID
- CDR0000304540
- Other IDs
- UCLA-0208074, NYH-CMC-0902-464, PHARMACIA-COXAON-0509-106
- Status last verified
- Aug 2012
- First submitted
- 5 Jun 2003
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Phase II Study of Preoperative Celecoxib/Paclitaxel/Carboplatin for Stage IIIA Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00062179
- Acronym / sponsor ID
- CDR0000304540
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Pharmacia
- Study start
- Mar 2003
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 6 Jun 2003 (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.
RATIONALE: Drugs used in chemotherapy such as paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug, may stop the growth of tumor cells by stopping blood flow to the tumor, and/or may block the enzymes necessary for tumor cell growth. Giving combination chemotherapy with celecoxib before surgery may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving paclitaxel together with carboplatin followed by surgery works compared to giving paclitaxel together with carboplatin and celecoxib followed by surgery in treating patients with stage IIIA non-small cell lung cancer.
Detailed description
OBJECTIVES:
- Compare the complete pathological response rate and/or minimal residual microscopic disease in patients with stage IIIA non-small cell lung cancer treated with preoperative paclitaxel and carboplatin with vs without celecoxib.
- Compare the clinical response rate in patients treated with these regimens.
- Compare chemotherapy-related toxicity in patients treated with these regimens.
- Compare the time to progression, disease-free survival, and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to use of aspirin for prior cardiovascular disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1, 22, and 43. Patients also receive oral celecoxib twice daily beginning on day 1 and continuing until the morning of surgical resection.
- Arm II: Patients receive paclitaxel and carboplatin as in arm I and an oral placebo twice daily beginning on day 1 and continuing until the morning of surgical resection.
In both arms, patients undergo surgical resection and complete mediastinal lymph node dissection within 3-6 weeks after completion of chemotherapy. Patients resume oral celecoxib or placebo twice daily within 28-42 days after surgery and continue until 3 years from the date of randomization in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3-6 months.
PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paclitaxel/carboplatin/celecoxib | Experimental | Drug: carboplatin, Drug: celecoxib, Drug: paclitaxelPaclitaxel: 225 mg/m2 by 3-hour intravenous infusion Carboplatin: dosed at an AUC of 6 by the Calvert Formula Celecoxib: 400 mg po BID 3 cycles of paclitaxel and carboplatin 21 days apart celecoxib 3-7 days before first dose of chemotherapy |
| paclitaxel/Carboplatin/Placebo | Placebo comparator | Drug: carboplatin, Drug: paclitaxel, Other: PlaceboPaclitaxel: 225 mg/m2 by 3-hour intravenous infusion Carboplatin: dosed at an AUC of 6 by the Calvert Formula Placebo 3 cycles of paclitaxel and carboplatin 21 days apart Placebo 3-7 days before first dose of chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with biopsy proven non-small cell lung cancer clinical stage IIIA
- Mediastinoscopy positive N2 disease is mandatory
- The disease must be deemed potentially resectable by the thoracic surgeon
- Karnofsky performance status > 80%
- Pulmonary function must be acceptable for surgery according to institutional standards
Key exclusion criteria (12 listed)
- Patients with known hypersensitivity or allergic reactions to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates
- Hypersensitivity to paclitaxel
- Significant medical or psychiatric illness that would interfere with patient compliance
- Prior malignancy within the last 3 years with the exception of non-melanoma skin cancer
- Receiving other investigational agents during the course of this study or are < 3 weeks from completion of other clinical trial therapy
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 |
|---|---|---|
| carboplatinCarboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apart | Drug | paclitaxel/Carboplatin/Placebo, paclitaxel/carboplatin/celecoxib |
| celecoxibCelecoxib: 400 mg po BID celecoxib 3-7 days before first dose of chemotherapy | Drug | paclitaxel/carboplatin/celecoxib |
| paclitaxelPaclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apart | Drug | paclitaxel/Carboplatin/Placebo, paclitaxel/carboplatin/celecoxib |
| Placeboplacebo 3-7 days before first dose of chemotherapy | Other | paclitaxel/Carboplatin/Placebo |
Primary outcome
Rates of complete pathological response and/or minimal residual microscopic disease at 3 years
Time frame: 3 years
3 secondary outcomes
Clinical response at 3 years
Time frame: 3 years
Difference in time to progression, disease-free survival, and overall survival between Arm I and Arm II at 3 years
Time frame: 3 years
Toxicity in patients with paclitaxel/carboplatin/celecoxib vs. paclitaxel/carboplatin/placebo
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 3 Aug 2020.
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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.
Karen Rickard principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin, celecoxib and paclitaxel in people with Lung Cancer, run by Jonsson Comprehensive Cancer Center at 2 sites 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 16 inclusion and 12 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Rates of complete pathological response and/or minimal residual microscopic disease at 3 years (time frame: 3 years). 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 3 Aug 2020.