Viewing Study NCT00343408



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Last Modification Date: 2024-10-26 @ 9:25 AM
Study NCT ID: NCT00343408
Status: COMPLETED
Last Update Posted: 2023-08-04
First Post: 2006-06-22

Brief Title: AZD2171 and Standard Combination Chemotherapy in Advanced Non-Small Cell Lung Cancer or Colorectal Cancer
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 Selected Standard Chemotherapy Regimens CT in Patients With Advanced Incurable Non-Small Cell Lung Cancer NSCLC or Colorectal Cancer
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 blood flow to the tumor and by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy 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 standard combination 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 standard combination chemotherapy in treating patients with advanced non-small cell lung cancer NSCLC or colorectal cancer
Detailed Description: OBJECTIVES

Determine the recommended phase II dose of AZD2171 when administered with standard combination chemotherapy in patients with advanced non-small cell lung cancer or colorectal cancer
Determine the safety tolerability toxicity profile dose-limiting toxicities and pharmacokinetic profile of this treatment regimen
Assess the antitumor activity of this treatment regimen in patients with measurable disease
Correlate the toxicity profile with pharmacokinetics

OUTLINE This is a multicenter open-label dose-escalation study of AZD2171 Patients are assigned to 1 of 2 treatment groups according to disease

Group 1 non-small cell lung cancer Patients receive gemcitabine hydrochloride IV on days 1 and 8 and cisplatin IV on day 1 Patients also receive oral AZD2171 once daily beginning on day 2 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Group 2 colorectal cancer Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2 Patients also receive oral AZD2171 once daily beginning on day 3 Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity

In both groups cohorts of 3-6 patients receive escalating doses of AZD2171 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity

After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter

PROJECTED ACCRUAL A total of 30 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
CAN-NCIC-IND175 OTHER None None
CDR0000481443 OTHER PDQ None