Recurrent Non-small Cell Lung CancerPhase 2NCT00245063
AZD2171 in Treating Patients With Recurrent Small Cell Lung Cancer
A Phase 2 study testing cediranib maleate, laboratory biomarker analysis and pharmacogenomic studies in people with Recurrent Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well AZD2171 works in treating patients with recurrent small cell lung cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Non-small Cell Lung Cancer
- What is being tested?
- cediranib maleate, laboratory biomarker analysis and pharmacogenomic studies
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 must have histologically or cytologically confirmed small cell lung cancer
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan
- Patients must have received prior platinum-based chemotherapy; no more than 1 prior chemotherapy regimen is allowed
- Life expectancy of greater than 12 weeks
- Karnofsky performance status >= 50%
- Leukocytes >= 3,000/mcL
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- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Hemoglobin >= 8 g/dL
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) =< 2.5 × institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance > >= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- At present, the potential of AZD2171 for clinically significant drug interactions involving the CYP isozymes is unknown; the only documented interaction is with CYP IA agents/drugs; the other reported interactions were not seen in the dose ranges studied and appears to occur at levels far beyond what can be and will be delivered clinically; patients receiving CYP interactive concomitant medications should not be excluded from study, but those agents/drugs should be documented along with any associated AEs that occur; efforts should be made to switch patients with gliomas or brain metastases who are taking enzyme-inducing anticonvulsant agents to other medications
- AZD2171 has been shown to terminate fetal development in the rat, as expected for a process dependent on VEGF signaling; for this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to take oral medications on a regular basis
- Ability to understand and the willingness to sign a written informed consent document
- The following groups of patients will be considered to be at high risk for compromised left ventricular ejection fraction (LVEF): prior treatment with anthracyclines, prior treatment with trastuzumab, NYHA classification of, class II heart failure controlled with appropriate therapy, prior central thoracic radiotherapy including RT to the heart and history of myocardial infarction within 12 months; these patients are eligible for the study, but will require close monitoring
Who cannot join
- Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 30 days
- Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- Mean QTc > 500 msec (with Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome
- Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart
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- Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because AZD2171 is a VEGF inhibitor with known abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD2171, breastfeeding should be discontinued if the mother is treated with AZD2171
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD2171
- Patients with Class III or IV heart failure (NYHA) and those requiring concurrent use of drugs with proarrhythmic potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of AZD2171 in Patients With Recurrent Small Cell Lung Cancer
This phase II trial is studying how well AZD2171 works in treating patients with recurrent small cell lung cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the objective response rate of AZD 2171 in patients with recurrent small cell lung cancer (SCLC).
SECONDARY OBJECTIVES:
- To determine the overall survival and time to progression. II. To assess the toxicities associated with the administration of AZD 2171 for patients with recurrent SCLC.
III. To perform molecular correlative studies on archival tumor and peripheral blood.
OUTLINE: This is a multicenter study.
Patients receive oral AZD2171 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks.
- Conditions
- Recurrent Non-small Cell Lung Cancer
- Being tested
- cediranib maleate, laboratory biomarker analysis, pharmacogenomic studies
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cediranib maleateDrug
Also called AZD2171, Recentin
Given PO
laboratory biomarker analysisOther
Correlative studies
pharmacogenomic studiesOther
Also called Pharmacogenomic Study
Optional correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cediranib maleate) | Experimental | Patients receive oral AZD2171 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: cediranib maleate; Other: laboratory biomarker analysis; Other: pharmacogenomic studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startMar 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marianna Koczywas, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245063
- Sponsor's protocol ID
- NCI-2012-02837
- Other IDs
- PHII-64, N01CM62201, N01CM62209
- Status last verified
- Jun 2013
- First submitted
- 25 Oct 2005
- Last updated
- 2 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of AZD2171 in Patients With Recurrent Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00245063
- Acronym / sponsor ID
- NCI-2012-02837
- Conditions
- Recurrent Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 27 Oct 2005 (estimated)
- Results
- Posted 2 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well AZD2171 works in treating patients with recurrent small cell lung cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Detailed description
PRIMARY OBJECTIVES:
- To determine the objective response rate of AZD 2171 in patients with recurrent small cell lung cancer (SCLC).
SECONDARY OBJECTIVES:
- To determine the overall survival and time to progression. II. To assess the toxicities associated with the administration of AZD 2171 for patients with recurrent SCLC.
III. To perform molecular correlative studies on archival tumor and peripheral blood.
OUTLINE: This is a multicenter study.
Patients receive oral AZD2171 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (cediranib maleate) | Experimental | Drug: cediranib maleate, Other: laboratory biomarker analysis, Other: pharmacogenomic studiesPatients receive oral AZD2171 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histologically or cytologically confirmed small cell lung cancer
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan
- Patients must have received prior platinum-based chemotherapy; no more than 1 prior chemotherapy regimen is allowed
- Life expectancy of greater than 12 weeks
- Karnofsky performance status >= 50%
Key exclusion criteria (10 listed)
- Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 30 days
- Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- Mean QTc > 500 msec (with Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome
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 |
|---|---|---|
| cediranib maleateAlso: AZD2171, RecentinGiven PO | Drug | Treatment (cediranib maleate) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (cediranib maleate) |
| pharmacogenomic studiesAlso: Pharmacogenomic StudyOptional correlative studies | Other | Treatment (cediranib maleate) |
Primary outcome
Objective Response Rate
Time frame: Up to 4 weeks
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marianna Koczywas principal investigator
City of Hope Medical Center
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 cediranib maleate, laboratory biomarker analysis and pharmacogenomic studies in people with Recurrent Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) 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 17 inclusion and 10 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 2 Oct 2014. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate (time frame: Up to 4 weeks). 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 2 Oct 2014.