AZD2171 + Chemotherapy in Advanced NSCLC, Colorectal Cancer, or Other Cancer Suitable for Treatment With Capecitabine (Non-Small Lung Cancer Patients Closed to Enrollment as 8/9/07)
Colorectal Cancer, Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific
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, stage IV colon cancer, stage IV rectal cancer, unspecified adult solid tumor, protocol specific
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed diagnosis of 1 of the following: Non-small cell lung cancer (NSCLC) (closed to accrual as of 8/9/07) meeting 1 of the following stage criteria: Stage IIIB disease Patients without pleural effusion who are not candidates for combined modality treatment OR who were treated at centers where combined modality treatment is not considered standard treatment are eligible Stage IV disease Local or metastatic failure after prior surgery and/or radiotherapy Colorectal cancer Metastatic disease Considered suitable for first-line therapy with capecitabine Other tumor types Suitable for treatment with capecitabine No more than 2 prior chemotherapy regimens for advanced or metastatic disease Incurable by radiotherapy or surgery Clinically or radiologically documented disease No tumor marker elevation as the only evidence of disease No necrotic or hemorrhagic tumor or metastases No untreated brain or meningeal metastases Patients with previously treated stable brain metastases (by radiography or clinical exam) are eligible provided they are asymptomatic and do not require corticosteroids PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks (colorectal cancer patients) Hematopoietic Hemoglobin adequate Anemia allowed provided patient is well compensated with no evidence of recent bleeding Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No overt bleeding (i.e., ≥ 30 mL/episode) within the past 3 months Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) ALT or AST ≤ 2 times ULN (5 times ULN for documented liver metastases) Renal Creatinine ≤ 1.5 times ULN OR Creatinine clearance ≥ 50 mL/min No proteinuria > grade 1 Cardiovascular Resting systolic blood pressure ≤ 150 mm Hg AND/OR resting diastolic blood pressure ≤ 100 mm Hg (in the presence or absence of a stable dose of antihypertensive medication) Mean QTc ≤ 470 msec (with Bazetts correction) by ECG LVEF > 50% for patients with prior anthracyclines/trastuzumab or cardio-toxic agents No untreated or uncontrolled cardiovascular condition No symptomatic cardiac dysfunction No poorly controlled hypertension No history of labile hypertension No history of poor compliance with antihypertensive medication No history of familial long QT syndrome Pulmonary No clinically relevant hemoptysis (i.e., ≥ 5 mL fresh blood) within the past 4 weeks Patients with only flecks of blood in their sputum are eligible Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective (double-method for females; barrier method for males) contraception No prior allergic reaction to drugs containing Cremophor EL® (NSCLC patients [closed to accrual as of 8/9/07]) No peripheral neuropathy > grade 1 (NSCLC patients [closed to accrual as of 8/9/07]) No dihydropyrimidine dehydrogenase deficiency (colorectal cancer patients) No history of severe hand-foot syndrome after treatment with fluoropyrimidines (colorectal cancer patients) No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or other curatively treated solid tumor No active or uncontrolled infection No other serious illness or medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No prior antiangiogenesis therapy Chemotherapy At least 4 weeks since prior single-agent non-platinum-containing chemotherapy (6 weeks for nitrosoureas or mitomycin) for metastatic disease (NSCLC patients [closed to accrual as of 8/9/07]) No more than 1 prior single-agent non-platinum-containing chemotherapy regimen for metastatic disease At least 6 months since prior adjuvant or neoadjuvant chemotherapy No prior taxane therapy (NSCLC patients [closed to accrual as of 8/9/07]) No prior chemotherapy for metastatic disease (colorectal cancer patients) No prior capecitabine (colorectal cancer patients) Endocrine therapy See Disease Characteristics At least 4 weeks since prior corticosteroids Radiotherapy See Disease Characteristics At least 21 days since prior palliative radiotherapy except for low-dose non-myelosuppressive radiotherapy with approval At least 6 months since prior adjuvant radiotherapy Surgery See Disease Characteristics At least 14 days since prior major surgery Other Recovered from prior therapy At least 14 days since prior epidermal growth factor receptor inhibitor therapy Concurrent oral anticoagulants (e.g., warfarin) allowed provided INR is strictly monitored No other concurrent investigational therapy No other concurrent anticancer therapy No concurrent prophylactic pyridoxine (vitamin B_6) for hand-foot syndrome (colorectal or other tumor type patients) Use of pyridoxine after the onset of hand-foot syndrome allowed at the discretion of the physician
Sites / Locations
- Ottawa Hospital Regional Cancer Centre - General Campus
- Princess Margaret Hospital
Arms of the Study
Arm 1
Experimental
AZD2171 + Standard chemotherpay regimens