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| Descriptive Information Fields | |||||
| Brief Title † | 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer | ||||
| Official Title † | A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug. PURPOSE: This phase II trial is studying how well giving gemcitabine together with 3-AP works in treating patients with unresectable or metastatic pancreatic cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients are followed at 1 month, every 2 months for 6 months, and then every 3 months for 18 months. PROJECTED ACCRUAL: A total of 50-95 patients will be accrued for this study within 18-24 months. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Objective response rate (partial and complete response) as assessed by RECIST criteria [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Progression-free and overall survival [ Designated as safety issue: No ] Safety and feasibility [ Designated as safety issue: Yes ] |
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| Condition † | Pancreatic Cancer | ||||
| Intervention † | Drug: gemcitabine hydrochloride Drug: triapine |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
| Start Date † | January 2003 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, Belgium, United Kingdom | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00064051 | ||||
| Organization ID | CDR0000306461 | ||||
| Secondary IDs †† | VION-CLI-031 | ||||
| Study Sponsor † | Vion Pharmaceuticals | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | July 8, 2003 | ||||
| Last Updated Date | August 23, 2008 | ||||