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Sponsored by: |
National Cancer Institute of Canada |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00265876 |
RATIONALE: AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving AZD0530 together with gemcitabine may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of AZD0530 when given together with gemcitabine and to see how well they work in treating patients with locally advanced or metastatic pancreatic cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
Pancreatic Cancer |
Drug: AZD0530 Drug: gemcitabine hydrochloride |
Phase I Phase II |
MedlinePlus related topics: | Cancer Pancreatic Cancer |
ChemIDplus related topics: | Gemcitabine hydrochloride Gemcitabine Pancrelipase Ultrase |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Study of AZD0530 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Phase I
Phase II
OUTLINE: This is a phase I, open-label, multicenter, dose-escalation study of AZD0530 followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of AZD0530 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 60 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 pancreatic adenocarcinoma
Clinically or radiologically documented disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan (phase II)
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Gastrointestinal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or gemcitabine given concurrently with radiotherapy as a radiosensitizer
Endocrine therapy
Radiotherapy
Surgery
Other
The following drugs must not be used for 1-2 weeks before, during, and for 1-2 weeks after completion of study treatment:
Canada, British Columbia | |||||
British Columbia Cancer Agency - Vancouver Cancer Centre | |||||
Vancouver, British Columbia, Canada, V5Z 4E6 | |||||
Canada, Ontario | |||||
Ontario Cancer Institute at Princess Margaret Hospital | |||||
Toronto, Ontario, Canada, M4X 1K9 | |||||
Ottawa Hospital Regional Cancer Centre - General Campus | |||||
Ottawa, Ontario, Canada, K1H 8L6 |
National Cancer Institute of Canada |
Study Chair: | Malcolm J. Moore, MD | Princess Margaret Hospital, Canada |
Investigator: | Sharlene Gill, MD | British Columbia Cancer Agency |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000450844, CAN-NCIC-IND173, ZENECA-CAN-NCIC-IND173 |
First Received: | December 14, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00265876 |
Health Authority: | United States: Federal Government |
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