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Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Recurrent Non-small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 ...

Detailed Description

PRIMARY OBJECTIVES: I. Evaluate the response rate in patients with relapsed non-small cell lung cancer treated with AZD2171 and pemetrexed disodium. SECONDARY OBJECTIVES: I. Assess the progression-...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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
  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2014

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT00410904

    Start Date

    October 1 2006

    End Date

    March 1 2014

    Last Update

    April 13 2018

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, United States, 21201

    2

    Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, United States, 48201