Status:
COMPLETED
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)
Lead Sponsor:
NCIC Clinical Trials Group
Conditions:
Colorectal Cancer
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, ca...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose and recommended phase II dose of AZD2171 when administered in combination with standard chemotherapy comprising either paclitaxel and carboplatin OR...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 21 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00107250
Start Date
January 21 2005
End Date
January 18 2011
Last Update
August 4 2023
Active Locations (2)
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1
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9