Lung CancerPhase 2NCT00068653
Gefitinib and Celecoxib in Treating Patients With Refractory Non-Small Cell Lung Cancer
A Phase 2 study testing Celecoxib and ZD1839 in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Combining gefitinib with celecoxib may kill more tumor cells. 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?
- Celecoxib and ZD1839
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to May 2008
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Progression of disease during platinum-based (cisplatin or carboplatin) chemotherapy or within 3 months of completing chemotherapy
- Treatment with other agents since prior platinum-based chemotherapy allowed
- Measurable disease
- Target lesions within a prior radiation field must have documented evidence of progression at least 8 weeks after the completion of radiotherapy
- No active brain or leptomeningeal metastases
- Treated brain metastases allowed at least 4 weeks after the completion of appropriate therapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN (if alkaline phosphatase is no greater than ULN)
- Alkaline phosphatase no greater than 5 times ULN (if AST and ALT are greater than ULN)
- No history of chronic hepatitis
Renal
- Creatinine no greater than 1.5 times ULN
Cardiovascular
- No active thromboembolic event within the past 4 weeks
- No uncontrolled congestive heart failure
- No uncontrolled angina
- No myocardial infarction and/or stroke within the past 6 months
Pulmonary
- No evidence of clinically active interstitial lung disease
Gastrointestinal
- No history of gastrointestinal bleeding within the past 6 months
- No history of peptic ulcer disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must weigh at least 110 pounds (50 kg)
- HIV negative
- No allergy to sulfonamides
- No allergy to any NSAID, including celecoxib
- No known severe hypersensitivity to gefitinib or any of its excipients
- No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No history of dementia, active psychiatric disorder, or any other condition that would preclude study compliance
- No other concurrent serious medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior epidermal growth factor receptor inhibitor
- No concurrent biologic therapy
Chemotherapy
- See Disease Characteristics
- More than 2 weeks since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- Recovered from prior radiotherapy
Surgery
- Recovered from prior surgery
Other
- Recovered from prior therapy
- More than 2 weeks since prior investigational therapy
- More than 1 week since prior fluconazole
- More than 30 days since prior participation in another investigational agent clinical trial
- More than 30 days since prior chronic nonsteroidal anti-inflammatory drugs (NSAIDs), including celecoxib or rofecoxib
- No prior gefitinib
- No prior cyclooxygenase-2 (COX-2) inhibitor or another clinical trial for NSCLC
- No other concurrent NSAIDs
- Concurrent aspirin allowed (not to exceed 325 mg/day)
- No other concurrent COX-2 inhibitors
- No concurrent lithium
- No concurrent fluconazole
- No concurrent use of any of the following:
- Phenytoin
- Carbamazepine
- Barbiturates
- Rifampin
- Phenobarbital
- Hypericum perforatum
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
About this study
Official title: Phase II Study of the Combination of ZD1839 (Iressa) and Celecoxib in Patients With Platinum Refractory Non-Small Cell Lung Cance
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Combining gefitinib with celecoxib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gefitinib with celecoxib in treating patients who have non-small cell lung cancer that is refractory to platinum-based chemotherapy (such as cisplatin or carboplatin).
Read the detailed description
OBJECTIVES:
Primary
- Determine the response rate in patients with platinum-refractory non-small cell lung cancer treated with gefitinib and celecoxib.
Secondary
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive oral gefitinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for up to 6 weeks.
PROJECTED ACCRUAL: A total of 18-27 patients will be accrued for this study within 22 months.
- Conditions
- Lung Cancer
- Being tested
- Celecoxib, ZD1839
- Keywords
- recurrent 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.
CelecoxibDrug
Also called Celebrex
Celecoxib 400mg orally two times a day, taken with meals.
ZD1839Drug
Also called Iressa, Gefitinib
ZD1839 250 mg po every day, taken with or without food.
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib & ZD1839 | Experimental | Celecoxib: 400mg orally two times a day, taken with meals.
ZD1839: 250 mg po every day, taken with or without food. Receives: Drug: Celecoxib; Drug: ZD1839 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
CT scan chest/abdomen; Assessments of complete response (CR) or partial response (PR)require confirmation 4 weeks or later.
Measured: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation
Secondary outcomes (3)
Progression-free survival (PFS)
Measured: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation
Overall survival
Measured: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation
Toxicity of this drug combination
Measured: Every 2 weeks; Every month after 4 cycles if the patient has not developed > Grade 2 toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2003 (estimated)
- Study startJun 2003
- Primary completionOct 2007
- Study completionMay 2008
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shirish M. Gadgeel, MD, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068653
- Sponsor's protocol ID
- CDR0000327805
- Other IDs
- P30CA022453, WSU-C-2563, ZENECA-1839US/0252
- Status last verified
- Apr 2013
- First submitted
- 10 Sep 2003
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Combination of ZD1839 (Iressa) and Celecoxib in Patients With Platinum Refractory Non-Small Cell Lung Cance
- ClinicalTrials.gov ID
- NCT00068653
- Acronym / sponsor ID
- CDR0000327805
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 11 Sep 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: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Combining gefitinib with celecoxib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gefitinib with celecoxib in treating patients who have non-small cell lung cancer that is refractory to platinum-based chemotherapy (such as cisplatin or carboplatin).
Detailed description
OBJECTIVES:
Primary
- Determine the response rate in patients with platinum-refractory non-small cell lung cancer treated with gefitinib and celecoxib.
Secondary
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive oral gefitinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for up to 6 weeks.
PROJECTED ACCRUAL: A total of 18-27 patients will be accrued for this study within 22 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celecoxib & ZD1839 | Experimental | Drug: Celecoxib, Drug: ZD1839Celecoxib: 400mg orally two times a day, taken with meals. ZD1839: 250 mg po every day, taken with or without food. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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: CelebrexCelecoxib 400mg orally two times a day, taken with meals. | Drug | Celecoxib & ZD1839 |
| ZD1839Also: Iressa, GefitinibZD1839 250 mg po every day, taken with or without food. | Drug | Celecoxib & ZD1839 |
Primary outcome
Response rate
Time frame: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation
CT scan chest/abdomen; Assessments of complete response (CR) or partial response (PR)require confirmation 4 weeks or later.
3 secondary outcomes
Progression-free survival (PFS)
Time frame: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation
Overall survival
Time frame: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation
Toxicity of this drug combination
Time frame: Every 2 weeks; Every month after 4 cycles if the patient has not developed > Grade 2 toxicity
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 29 Apr 2013.
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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.
Shirish M. Gadgeel, MD study chair
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib and ZD1839 in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute 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?
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 29 Apr 2013. 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 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?
Response rate (time frame: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation). 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 29 Apr 2013.