CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
bortezomib +2 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Histologically confirmed persistent or recurrent ovarian epithelial or primary peritoneal carcinoma
  • ✓Measurable disease: ≥20 mm by conventional imaging or ≥10 mm by spiral CT
  • ✓No more than 1 platinum-based chemotherapy regimen for primary disease (second paclitaxel-containing regimen allowed if no prior paclitaxel)
  • ✓Platinum-sensitive disease: treatment-free interval >6 months but <12 months after platinum-based regimen without progressive disease
Key exclusion· 9
  • ✕Sensory or motor neuropathy greater than grade 1
  • ✕Myocardial infarction within 6 months
  • ✕Cerebrovascular event or transient ischemic attack within 6 months
  • ✕Acute ischemia or significant conduction abnormality on ECG (e.g., left anterior hemiblock with right bundle branch block, or second/third degree AV block)

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

Search/NCT00023712
NCT00023712Phase 2Completed
CompareCT.gov

A Phase II Evaluation of Bortezomib (Velcade™, PS-341, NSC #681239, IND #58443) in the Treatment of Persistent or Recurrent Platinum-Sensitive Epithelial Ovarian or Primary Peritoneal Cancer

National Cancer Institute (NCI)·interventional·Posted Jan 27, 2003·Updated Jul 30, 2019

In Brief

A Phase 2 clinical trial evaluating bortezomib, laboratory biomarker analysis, and 1 other intervention for Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial Cancer. Completed, enrolled 58 participants across 1 site.

Detailed Summary

Phase II trial to study the effectiveness of bortezomib in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
CountriesUnited States
CollaboratorsGynecologic Oncology Group

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartNov 5, 2001
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 23.4 years ago

Interventions

bortezomibdrug

Given IV

laboratory biomarker analysisother

Correlative studies

pharmacological studyother

Correlative studies