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Recurrent Non-small Cell Lung CancerPhase 2NCT00410904

AZD2171 and Pemetrexed Disodium in Treating Patients With Relapsed Non-Small Cell Lung Cancer

A Phase 2 study testing cediranib maleate and pemetrexed disodium in people with Recurrent Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial is studying how well giving AZD2171 together with pemetrexed disodium works in treating patients with relapsed non-small cell lung cancer. AZD2171 and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 and pemetrexed disodium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
Oct 2006to Mar 2014
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

  • Histologically or cytologically confirmed non-small cell lung cancer
  • Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan
  • Lesions in a previously irradiated area are considered measurable provided there has been an increase of >= 10 mm since completion of radiotherapy
  • Received 1-2 prior regimens, including 1 doublet chemotherapy regimen, AND meets 1 of the following criteria:
  • No prior bevacizumab (cohort A)
  • Patients with squamous cell carcinoma, treated and controlled brain metastases, or history of hemoptysis allowed
Show all 85Show fewer
  • Received 1-2 prior regimens*, including 1 doublet chemotherapy regimen, AND meets 1 of the following criteria:
  • Previously treated with bevacizumab (cohort B)
  • No discontinuation of bevacizumab for uncontrollable hypertension and/or life-threatening bleeding
  • Must have disease progression after prior bevacizumab (NOTE: *Prior adjuvant therapy is considered 1 regimen if disease progression occurred within 1 year of completion of therapy; if a regimen was discontinued within 2 courses for allergic reaction or unacceptable drug-specific toxicity, that regimen dose not count)
  • No large pleural effusion or ascites unless drained
  • No active brain metastases by brain MRI or CT scan within the past 4 weeks
  • Patients with treated, controlled brain metastasis allowed provided they are neurologically stable without seizures within the past 3 weeks
  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • WBC >= 3,000/mm^3
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • AST and ALT =< 2.5 times ULN (< 5 times ULN if liver metastases present)
  • Creatinine normal OR creatinine clearance >= 60 mL/min
  • Urine protein =< 1+ on 2 consecutive dipsticks taken >= 1 week apart
  • No significant hemorrhage (i.e., > 30 mL in 1 episode) within the past 3 months
  • No significant hemoptysis (i.e., > 5 mL fresh blood in 1 episode) within the past 4 weeks
  • No active gastrointestinal disease that may affect the ability of the patient to absorb AZD2171
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171 or pemetrexed disodium
  • No other malignancies within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situation that would preclude study compliance
  • No New York Heart Association class III or IV heart disease
  • Mean QTc < 470 msec by ECG
  • No history of familial long QT syndrome
  • Fertile patients must use effective contraception
  • No resting blood pressure (BP) consistently > 140/90 mm Hg; Patients whose BP is controlled after starting, adjusting, or increasing medication allowed
  • LVEF normal by MUGA or echocardiogram for patients at increased risk for left ventricular dysfunction, as evidenced by any of the following:
  • Prior treatment with anthracyclines
  • New York Heart Association class III or IV heart disease or controlled class II disease
  • Prior central thoracic radiotherapy, including radiotherapy to the heart
  • Myocardial infarction within the past 12 months
  • At least 4 weeks since prior definitive chest radiotherapy (> 60 Gy) and recovered
  • At least 3 months since prior craniotomy for resection of brain metastasis
  • At least 3 weeks since prior radiotherapy for brain metastases
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
  • At least 2 weeks since prior palliative radiotherapy
  • At least 2 weeks since prior surgery (excluding the placement of vascular access or drainage of pleural effusion or ascites) and recovered
  • No inability or unwillingness to take folic acid, cyanocobalamin (vitamin B12), or dexamethasone
  • No prior pemetrexed disodium
  • At least 5 half-lives since prior and no concurrent drugs or biologics with proarrythmic potential including:
  • Amiodarone hydrochloride
  • Arsenic trioxide
  • Bepridil
  • Chloroquine
  • Chlorpromazine
  • Cisapride
  • Clarithromycin
  • Disopyramide
  • Dofetilide
  • Domperidone
  • Droperidol
  • Erythromycin
  • Halofantrine
  • Haloperidol
  • Ibutilide
  • Mesoridazine
  • Methadone
  • Pentamidine
  • Pimozide
  • Procainamide
  • Sotalol
  • Sparfloxacin
  • Thioridazine
  • Not pregnant or nursing
  • More than 30 days since prior investigational agents and recovered
  • No aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) for 2 days before, during, and for 2 days after pemetrexed disodium administration: Low-dose aspirin (≤ 325 mg/day) for vascular disorders allowed
  • No long-acting NSAIDs (e.g., naproxen, piroxicam, diflunisal, nabumetone, or celecoxib) for 5 days before, during, and for 2 days after pemetrexed disodium
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer agents or therapies
  • No other concurrent investigational agents
  • Life expectancy > 12 weeks
  • No concurrent medications that can markedly affect renal function (e.g., vancomycin or amphotericin)
  • Negative pregnancy test
  • Relapsed disease

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: Phase 2 Study of AZD2171 (NSC 732208) in Combination With Pemetrexed in Relapsed Non-Small Cell Lung Cancer (NOS: 10029514)

This phase II trial is studying how well giving AZD2171 together with pemetrexed disodium works in treating patients with relapsed non-small cell lung cancer. AZD2171 and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. AZD2171 may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving AZD2171 together with pemetrexed disodium may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Evaluate the response rate in patients with relapsed non-small cell lung cancer treated with AZD2171 and pemetrexed disodium.

SECONDARY OBJECTIVES:

  1. Assess the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to prior bevacizumab treatment (yes vs no).

Patients receive oral AZD2171 once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks* in the absence of disease progression or unacceptable toxicity.

[Note: * The first course is 4 weeks in duration; all subsequent courses are 3 weeks in duration.]

After completion of study treatment, patients are followed at 4 weeks and then periodically thereafter.

Being tested
cediranib maleate, pemetrexed disodium
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

  • pemetrexed disodiumDrug

    Also called ALIMTA, LY231514, MTA

Study groups in NCT00410904
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral AZD2171 once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: cediranib maleate; Drug: pemetrexed disodium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate (Complete and Partial) 2 Separate Cohorts of Relapsed NSCLC Cohort A: Pts Who Have Received Prior Chemo w/o Ever Having Received Bevacizumab. Cohort B: Pts Who Have Received Prior Bevacizumab.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0) for target lesions and assessed by MRI or CT:

    Complete Response (CR): Disappearance of all target lesions

    Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD

    Overall Response (OR) = CR + PR, the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started)

    Measured: Up to 4 years

Secondary outcomes (2)

  1. Progression-free Survival

    Estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of all PFS and OS statistics will be calculated. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: The duration of time from start of treatment to time of progression, assessed up to 4 years

  2. Overall Survival

    Estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of all PFS and OS statistics will be calculated.

    Measured: The time from start of treatment to time of death, assessed up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionJul 2013
  4. Study completionMar 2014

Resources

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00410904
Sponsor's protocol ID
NCI-2009-00165
Other IDs
NCI-2009-00165, CDR0000517316, 2006-042, 7389, P30CA022453, U01CA062487
Status last verified
Mar 2018
First submitted
11 Dec 2006
Last updated
13 Apr 2018

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cediranib maleate and pemetrexed disodium in people with Recurrent Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) 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 85 inclusion and 0 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 13 Apr 2018. 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. 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 22 Sep 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?

Response Rate (Complete and Partial) 2 Separate Cohorts of Relapsed NSCLC Cohort A: Pts Who Have Received Prior Chemo w/o Ever Having Received Bevacizumab. Cohort B: Pts Who Have Received Prior Bevacizumab. (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00410904.

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 13 Apr 2018.

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