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About
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.
Full 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-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.
Enrollment
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Inclusion and exclusion criteria
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:
Received 1-2 prior regimens*, including 1 doublet chemotherapy regimen, AND meets 1 of the following criteria:
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:
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:
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:
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
Primary purpose
Allocation
Interventional model
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60 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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