CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
topotecan hydrochloridedrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer that is recurrent
  • ✓Measurable disease: ≥1 unidimensionally measurable lesion ≥20 mm by conventional techniques OR ≥10 mm by spiral CT, with at least 1 target lesion not in previously irradiated field
  • ✓Received exactly 1 prior platinum-based chemotherapy regimen for primary disease (carboplatin, cisplatin, or other organoplatinum compound)
  • ✓Platinum-sensitive disease: treatment-free interval >6 months after prior response to platinum-based regimen, without clinical evidence of progressive disease (non-platinum maintenance/consolidation therapy not counted in interval)
Key exclusion· 8
  • ✕Prior topotecan therapy
  • ✕Other prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimen
  • ✕More than 1 prior non-cytotoxic (biologic or cytostatic) regimen for recurrent disease (e.g., monoclonal antibodies, cytokines, or small molecule inhibitors)
  • ✕Sensory or motor neuropathy >grade 1

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

Search/NCT00114166
NCT00114166Phase 2Completed
CompareCT.gov

A Randomized Phase II Evaluation of Topotecan (NSC #609699) Administered Daily x 5 Every 3 Weeks vs Weekly Topotecan in the Treatment of Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Gynecologic Oncology Group·interventional·Posted Jun 14, 2005·Updated Jul 24, 2018

In Brief

A Phase 2 clinical trial evaluating topotecan hydrochloride for Fallopian Tube Cancer and 2 related conditions. Completed, enrolled 81 participants across 78 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving topotecan in different dosing schedules may kill more tumor cells. PURPOSE: This phase II trial is studying how well topotecan works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 14, 2005
Enrollment StartJan 1, 2005
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 21.1 years ago

Interventions

topotecan hydrochloridedrug