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Trial: NCT00003276 [RDF]

Label NCT00003276
Slug nct00003276
Trialid NCT00003276
Lookup name NCT00003276
Provenance http://clinicaltrials.gov/show/NCT00003276?displayxml=true
Lastchanged date July 1, 2016
Firstreceived results date
Firstreceived date November 1, 1999
Id info nct id NCT00003276
Overall status Completed
Id info secondary id CDR0000066181
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 40
Number of arms 1
Is section 801 No
Is fda regulated Yes
Brief title Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer
Acronym
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 https://clinicaltrials.gov/show/NCT00003276
Study design Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Source Alliance for Clinical Trials in Oncology
Primary completion date March 2001
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 08, 2016
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 bffcf2162b703ab38831cdd9f5004c25
Intervention browse 32294ec8f04d982903a26190b3c7293d
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group 7448cd1e7a8abeb088879436c5859fa1
Oversight info United States: Federal Government (Oversight_info)
Eligibility 51c2769db616691ec973fd0d0eb85b95
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 4048c6f2b4da55233c02056eaf30a4d7, f9260f7cd70817ba8c7680e6fe96e963
References None
Primary outcomes af4361aa89d4e711cbe977ee6f197736
Removed countries None
Overall officials 1853920a7ab0a47cf2d3ba78f448b12a