AZD2171 and Standard Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer or Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00343408|
Recruitment Status : Completed
First Posted : June 23, 2006
Last Update Posted : November 9, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Lung Cancer||Drug: cediranib maleate Drug: cisplatin Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Drug: oxaliplatin||Phase 1|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2005|
|Study Completion Date :||September 2008|
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): NCT00343408
|Ottawa Hospital Regional Cancer Centre - General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Jewish General Hospital - Montreal|
|Montreal, Quebec, Canada, H3T 1E2|
|Study Chair:||Gerald Batist, MD||Jewish General Hospital|
|Study Chair:||Eric X. Chen, MD, PhD||Princess Margaret Hospital, Canada|
|Study Chair:||Glenwood D. Goss, MD, BCh, FCP, FRCPC||Ottawa Regional Cancer Centre|