Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107250
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2005-04-05
Brief Title:
AZD2171 Chemotherapy in Advanced NSCLC Colorectal Cancer or Other Cancer Suitable for Treatment With Capecitabine Non-Small Lung Cancer Patients Closed to Enrollment as 8907
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 8907 colorectal cancer or other cancer suitable to capecitabine treatment
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 8907 colorectal cancer or other cancer suitable to capecitabine treatment
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 capecitabine in patients with advanced incurable non-small cell lung cancer closed to accrual as of 8907 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 8907 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
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 8907 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 8907 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000422357 | OTHER | PDQ | None |
| CAN-NCIC-IND171 | OTHER | None | None |