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)

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