CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
gemcitabine hydrochloride +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically confirmed carcinoma of undetermined origin with adenocarcinoma, poorly differentiated non-small cell carcinoma, or poorly differentiated squamous cell carcinoma
  • ✓Primary site not identified after comprehensive diagnostic evaluation (history, physical, labs, imaging, and immunostaining)
  • ✓Measurable disease present
  • ✓Age 18 and over
Key exclusion· 11
  • ✕Neuroendocrine tumors
  • ✕Women with axillary node involvement only
  • ✕Women with adenocarcinoma of the peritoneum
  • ✕Carcinoma involving only 1 site with resectable tumor at that site

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00066781
NCT00066781Phase 2Completed
CompareCT.gov

A Phase II Study Of Gemcitabine (GEMZAR) And Irinotecan (CPT-11) In Previously Untreated Patients With Measurable Disease With Unknown Primary Carcinoma

Alliance for Clinical Trials in Oncology·interventional·Posted Aug 7, 2003·Updated Apr 4, 2017

In Brief

A Phase 2 clinical trial evaluating gemcitabine hydrochloride and irinotecan hydrochloride for Carcinoma of Unknown Primary. Completed, enrolled 31 participants across 4 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy such as gemcitabine and irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with cancer of unknown primary origin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma of Unknown Primary
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2003
Enrollment StartFeb 1, 2004
Primary CompletionApr 1, 2008
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 22.9 years ago

Interventions

gemcitabine hydrochloridedrug

Given IV

irinotecan hydrochloridedrug

Given IV