AZD2171 and Standard Combination Chemotherapy in Advanced Non-Small Cell Lung Cancer or Colorectal Cancer
Colorectal Cancer, Lung Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed diagnosis of 1 of the following: Non-small cell lung cancer (NSCLC), meeting 1 of the following criteria: Stage IIIB disease No pleural effusion and not a candidate for a combined modality treatment Stage IV disease Local or metastatic failure after surgery and/or radiotherapy Colorectal cancer (CRC) Advanced and/or metastatic disease Suitable for first-line therapy with oxaliplatin, leucovorin calcium, and fluorouracil (FOLFOX-6) Clinically or radiologically documented disease No tumor marker elevation as sole evidence of disease No necrotic/hemorrhagic metastases or tumor No untreated brain or meningeal metastases Previously treated, radiologic or clinical evidence of stable brain metastases allowed provided disease is asymptomatic and corticosteroids are not required PATIENT CHARACTERISTICS: ECOG performance status 0-2 Hemoglobin normal Absolute granulocyte count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min Bilirubin ≤ 1.5 times ULN AST or ALT ≤ 2 times ULN (5 times ULN if liver involvement) Proteinuria ≤ grade 1 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of other malignancies except adequately treated nonmelanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥ 5 years No untreated and/or uncontrolled cardiovascular conditions or symptomatic cardiac dysfunction No resting blood pressure (BP) consistently higher than systolic BP > 150 mm Hg and diastolic BP > 100 mm Hg (in the presence or absence of a stable dose of antihypertensive medication) No poorly controlled hypertension, history of labile hypertension, or poor compliance with antihypertensive medication No overt bleeding (≥ 30 mL bleeding/episode) within the past 3 months No clinically relevant hemoptysis (≥ 5 mL fresh blood) within the past 4 weeks Flecks of blood in sputum allowed No active or uncontrolled infections No serious illnesses or medical conditions that would preclude compliance with study requirements No mean QTc with Bazett's correction > 470 msec No history of familial long QT syndrome No peripheral neuropathy > grade 1 No dihydropyrimidine dehydrogenase deficiency or history of severe hand-foot syndrome after fluoropyrimidines (for patients with CRC) PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from prior therapy At least 6 months since prior adjuvant or neoadjuvant therapy At least 6 months since prior adjuvant radiotherapy At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) (for patients with NSCLC) At least 4 weeks since prior and no concurrent corticosteroids At least 3 weeks since prior palliative radiotherapy and recovered Concurrent palliative radiotherapy allowed At least 2 weeks since prior epidermal growth factor receptor inhibitor therapy At least 2 weeks since prior major surgery No more than 1 prior single-agent, nonplatinum-containing chemotherapy regimen for metastatic disease (for patients with NSCLC) No prior gemcitabine hydrochloride (for patients with NSCLC) No prior oxaliplatin (for patients with CRC) No prior angiogenesis inhibitor No prior chemotherapy for advanced/metastatic disease (for patients with CRC) No other concurrent experimental drugs or anticancer therapy
Sites / Locations
- Ottawa Hospital Regional Cancer Centre - General Campus
- Princess Margaret Hospital
- Jewish General Hospital - Montreal