CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
gemcitabine hydrochloride +1 moredrug
Likely dose
Gemcitabine and tanespimycin (17-AAG) IV; specific doses not provided in trial descriptionAI-extracted
Key inclusion· 5
  • ✓Diagnosis of ovarian epithelial or primary peritoneal cavity cancer with relapsed or persistent disease
  • ✓Platinum-resistant disease: failure of complete response to initial platinum therapy, recurrence <6 months after platinum, or contraindication to platinum
  • ✓Measurable or evaluable disease (including rising CA-125 ≥2× ULN if no other disease indicators)
  • ✓Accessible disease patients must be willing to undergo tumor biopsies
Key exclusion· 9
  • ✕CNS metastases
  • ✕Significant cardiac disease: NYHA class III/IV, MI within past year, uncontrolled dysrhythmias, poorly controlled angina, serious ventricular arrhythmia, QTc ≥500 msec, LBBB, or congenital long QT syndrome
  • ✕Active ischemic heart disease within past 12 months or cardiac toxicity after anthracyclines; cardiac symptoms ≥grade 2
  • ✕Ejection fraction ≤40% by ECHO (if prior anthracycline therapy)

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

Search/NCT00093496
NCT00093496Phase 2Completed
CompareCT.gov

A Phase II Trial Of Gemcitabine in Combination With 17-Allylaminogeldamycin (17-AAG) In Advanced Epithelial Ovarian And Primary Peritoneal Carcinoma

National Cancer Institute (NCI)·interventional·Posted Oct 8, 2004·Updated May 20, 2014

In Brief

A Phase 2 clinical trial evaluating gemcitabine hydrochloride and tanespimycin for Primary Peritoneal Cavity Cancer and 3 related conditions. Completed, enrolled 29 participants across 1 site.

Detailed Summary

Phase II trial to study the effectiveness of gemcitabine hydrochloride and tanespimycin in treating patients who have recurrent advanced ovarian epithelial or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing or die.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 8, 2004
Enrollment StartOct 1, 2007
Primary CompletionApr 1, 2010
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 21.7 years ago

Interventions

gemcitabine hydrochloridedrug

Given IV

tanespimycindrug

Given IV