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)
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|ClinicalTrials.gov Identifier: NCT00107250|
Recruitment Status : Completed
First Posted : April 6, 2005
Last Update Posted : April 8, 2020
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, carboplatin, or capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving AZD2171 together with chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of AZD2171 when given together with chemotherapy in treating patients with advanced non-small cell lung cancer (closed to enrollment as of 8/9/07), colorectal cancer, or other cancer suitable to capecitabine treatment.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: capecitabine Drug: carboplatin Drug: cediranib maleate Drug: paclitaxel||Phase 1|
- 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 capecitabine in patients with advanced incurable non-small cell lung cancer (closed to accrual as of 8/9/07), colorectal cancer, or other tumor types suitable for treatment with capecitabine.
- Determine the safety and tolerability of these regimens in these patients.
- Determine the toxicity profile and dose-limiting toxic effects of these regimens in these patients.
- Determine the pharmacokinetic profile of these regimens in these patients.
- Correlate the toxicity profile with the pharmacokinetic profile of these regimens in these patients.
- Determine the antitumor activity of these regimens in patients with measurable disease.
- Correlate patient outcome (response) with baseline (using tumor samples) and serial (using urine and plasma samples) biomarkers in patients treated with these regimens.
OUTLINE: This is an open-label, multicenter, dose-escalation study of AZD2171. Patients are assigned to 1 of 2 treatment groups according to diagnosis.
- Group 1 (non-small cell lung cancer) (closed to accrual as of 8/9/07): Patients receive paclitaxel IV and carboplatin IV on day 1. Patients also receive oral AZD2171 once daily on days 2-21 of course 1 and on days 1-21 of all subsequent courses. Treatment with paclitaxel and carboplatin repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Treatment with AZD2171 repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- Group 2 (colorectal or other tumor types): Patients receive oral capecitabine twice daily on days 1-14. Patients also receive oral AZD2171 once daily on days 8-21 of course 1 and on days 1-21 of all subsequent courses. Treatment with capecitabine repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with AZD2171 repeats every 21 days in the absence of disease progression or unacceptable toxicity.
In both groups, patients achieving a complete response (CR) OR a stable partial response (SPR) receive 2 additional courses beyond CR or SPR.
Cohorts of 3-6 patients per group receive escalating doses of AZD2171 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Up to 30 additional patients (20 in group 1 and 10 in group 2) will be treated at the MTD.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months until disease relapse.
PROJECTED ACCRUAL: A total of 3-35 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination With Standard Chemotherapy Regimens (CT) in Patients With Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer or Other Tumor Types Suitable for Treatment With Capecitabine|
|Actual Study Start Date :||January 13, 2005|
|Actual Primary Completion Date :||October 23, 2009|
|Actual Study Completion Date :||January 18, 2011|
|Experimental: AZD2171 + Standard chemotherpay regimens||
1000 mg/m2 orally twice daily (total of 2000 mg/m2 per day) for the first 14 days of a 21 day cycle for a maximum of 6-8 cycles.
AUC 6; IV; 30 minutes; Every 21 days for a maximum of 6-8 cycles
Drug: cediranib maleate
Given daily; orally with approximately 240 ml of water whilst in an upright position
200mg/m2; IV; 3 hours; Every 21 days for a maximum of 6-8 cycles
- Dose limiting toxicity [ Time Frame: Each dose level ]To recommend phase II dose of AZD2171 when given orally daily in combination with standard chemotherapy in patients with advanced NSCLC or colon cancer or other tumour types suitable for treatment with capecitabine.
- Safety [ Time Frame: Each dose level ]safety, tolerability, toxicity profile, dose limiting toxicities and pharmacokinetic profile of AZD2171 and standard chemotherapy given in these combinations. The correlation, if any,between the toxicity profile and the pharmacokinetics will be determined.
- Anti-tumour activity [ Time Frame: Each dose level ]Assessing the anti-tumour activity of AZD2171 in combination with standard chemotherapy regimens in patients with measurable disease.
- Tumour Response [ Time Frame: Each dose level ]To correlate patient outcomes (response) with baseline (tumour) and serial (urine and plasma) biomarkers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107250
|Ottawa Hospital Regional Cancer Centre - General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Derek Jonker, MD||Ottawa Regional Cancer Centre|
|Study Chair:||Scott A. Laurie, MD, FRCPC||Ottawa Regional Cancer Centre|