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

Completed · Phase 2

Conditions studied: Recurrent Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00410904

Run by

National Cancer Institute (NCI)

People needed

60

Starts

2006-10-01

Expected to finish

2014-03-01

Last updated by the study team

2018-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
• Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.