Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Cancer Institute of Canada |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00245154 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving paclitaxel and carboplatin together with AZD2171 may kill more tumor cells. It is not yet known whether giving paclitaxel and carboplatin together with AZD2171 is more effective than giving paclitaxel and carboplatin together with a placebo in treating non-small cell lung cancer.
PURPOSE: This randomized phase II/III trial is studying how well giving paclitaxel and carboplatin together with AZD2171 works and compares it to giving paclitaxel and carboplatin together with placebo in treating patients with stage III or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: carboplatin Drug: cediranib maleate Drug: paclitaxel |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase II/III Double Blind Randomized Trial of AZD2171 Versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer |
Estimated Enrollment: | 750 |
Study Start Date: | September 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to gender, participating center, disease stage (IIIB vs IV), weight loss (≥ 5% vs < 5%), and prior adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, before each treatment course, after completion of study treatment, and every 3 months thereafter.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:
Stage IIIB disease
Measurable disease (phase II)
No untreated brain or meningeal metastases
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No clinically relevant hemoptysis (i.e., ≥ 5 mL fresh blood) within the past 4 weeks
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior antiangiogenesis therapy, including any of the following:
Chemotherapy
At least 12 months since prior adjuvant chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No potent inhibitors of CYP3A4 and 2C8, including any of the following drugs:
Study Chair: | Glenwood D. Goss, MD, BCh, FCP, FRCPC | Ottawa Hospital Regional Cancer Centre - General Campus |
Investigator: | Scott A. Laurie, MD, FRCPC | Ottawa Hospital Regional Cancer Centre - General Campus |
Study ID Numbers: | CDR0000450850, CAN-NCIC-BR24, ZENECA-CAN-NCIC-BR24, FHCRC-6107, UWCC-UW 6107, UWCC- 06-2707-H/B |
Study First Received: | October 25, 2005 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00245154 |
Health Authority: | United States: Federal Government |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms |
Lung Diseases Carboplatin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |