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Trial: NCT00003276 [RDF]

Label NCT00003276
Slug nct00003276
Trialid NCT00003276
Lookup name NCT00003276
Lastchanged date
Firstreceived results date
Firstreceived date
Id info nct id NCT00003276
Overall status Completed
Id info secondary id CDR0000066181
Biospec retention
Required header link text Link to the current record.
Enrollment 40
Number of arms 1
Is section 801
Is fda regulated
Brief title Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer
Official title A Phase II Study of CPT-11 in Patients With Advanced Gallbladder or Bile Duct Tumors
Study type Interventional
Id info nct alias
Completion date March 2001
Verification date July 2016
Why stopped
Id info org study id NCCTG-964252
Required header url
Study design
Source Alliance for Clinical Trials in Oncology
Primary completion date March 2001
Brief summary
Number of groups
Required header download date processed this data on August 24, 2018
Phase Phase 2
Start date March 1998
Has expanded access No
Biospec descr
Detailed description OBJECTIVES: I. Evaluate the objective tumor response rate in patients with advanced gallbladder or bile duct tumors treated with irinotecan. II. Evaluate time-to-progression, survival, and toxic effects associated with irinotecan given weekly for 4 weeks every 6 weeks in this patient population. OUTLINE: Patients receive a 90 minute continuous infusion of irinotecan on days 1, 8, 15, and 22 for 4 weeks, followed by a 2 week rest period. Courses of treatment are repeated every 42 days. Patients continue treatment in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for the next 4 years. PROJECTED ACCRUAL: Approximately 22-40 patients will be accrued for this study over 2-4 years.
Condition browse None
Intervention browse None
Responsible party None
Overall contact None
Overall contact backup None
Sponsor group None
Oversight info None
Eligibility None
Keywords recurrent gallbladder cancer, unresectable gallbladder cancer
Conditions Gallbladder Cancer
Locations 01f92604e018b2dae724c453ad90914c, 13dc3765be4da0e5a1400823c0ce89ac, 2519c9cf4e33c7dad4b8ef527535c08d More →
Links None
Results references 2dc6733d1f168810e8ec90913eaee9f7, d4a804fcfcd00963182cc25c24d691d4, PMID:12794246
Arm groups irinotecan (Arm Group)
Location countries Canada, United States
Interventions irinotecan hydrochloride (Intervention)
Secondary outcomes 56d1210dd6d56f70b7ea2bb18c3ec0bc, d97693cb3380bce92988e7fe5c723556
References None
Primary outcomes bf14198742d5bab90b574faa5eafa41e
Removed countries None
Overall officials None