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Sponsored by: |
National Cancer Institute of Canada |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00343408 |
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 | Intervention | Phase |
---|---|---|
Colorectal Cancer Lung Cancer |
Drug: cediranib maleate Drug: cisplatin Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Drug: oxaliplatin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, 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 |
Estimated Enrollment: | 30 |
Study Start Date: | August 2005 |
OBJECTIVES:
OUTLINE: This is a multicenter, open-label, dose-escalation study of AZD2171. Patients are assigned to 1 of 2 treatment groups according to disease.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of 1 of the following:
Non-small cell lung cancer (NSCLC), meeting 1 of the following criteria:
Stage IIIB disease
Colorectal cancer (CRC)
Clinically or radiologically documented disease
No untreated brain or meningeal metastases
PATIENT CHARACTERISTICS:
No clinically relevant hemoptysis (≥ 5 mL fresh blood) within the past 4 weeks
PRIOR CONCURRENT THERAPY:
At least 3 weeks since prior palliative radiotherapy and recovered
Canada, Ontario | |
Ottawa Hospital Regional Cancer Centre - General Campus | |
Ottawa, Ontario, Canada, K1H 8L6 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada, Quebec | |
Jewish General Hospital - Montreal | |
Montreal, Quebec, Canada, H3T 1E2 |
Study Chair: | Gerald Batist, MD | Jewish General Hospital |
Investigator: | Eric X. Chen, MD, PhD | Princess Margaret Hospital, Canada |
Investigator: | Glenwood D. Goss, MD, BCh, FCP, FRCPC | Ottawa Hospital Regional Cancer Centre - General Campus |
Study ID Numbers: | CDR0000481443, CAN-NCIC-IND175 |
Study First Received: | June 22, 2006 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00343408 History of Changes |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent colon cancer stage III colon cancer |
stage IV colon cancer recurrent rectal cancer stage III rectal cancer stage IV rectal cancer |
Antimetabolites Thoracic Neoplasms Immunologic Factors Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Leucovorin Rectal Diseases Oxaliplatin Cisplatin Respiratory Tract Diseases Lung Neoplasms Vitamins Micronutrients Gemcitabine |
Vitamin B Complex Digestive System Neoplasms Rectal Neoplasm Trace Elements Intestinal Diseases Antiviral Agents Immunosuppressive Agents Intestinal Neoplasms Recurrence Carcinoma Calcium, Dietary Digestive System Diseases Rectal Cancer Radiation-Sensitizing Agents Lung Diseases |
Antimetabolites Thoracic Neoplasms Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Leucovorin Rectal Diseases Oxaliplatin Neoplasms by Site Respiratory Tract Diseases |
Lung Neoplasms Vitamins Therapeutic Uses Micronutrients Gemcitabine Respiratory Tract Neoplasms Vitamin B Complex Neoplasms by Histologic Type Digestive System Neoplasms Growth Substances Enzyme Inhibitors Intestinal Diseases Antiviral Agents Immunosuppressive Agents Pharmacologic Actions |