CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 76 enrolled
Drug / intervention
cetuximab +1 morebiological
Likely dose
Not stated in record
Key inclusion· 10
  • Histologically confirmed squamous or non-squamous cell carcinoma of the cervix with advanced, persistent, or recurrent disease and documented progression
  • Not amenable to curative therapy
  • At least one unidimensionally measurable lesion ≥20 mm by conventional imaging or ≥10 mm by spiral CT
  • Age 18 and over
Key exclusion· 9
  • Pregnant or nursing
  • Other invasive malignancy within past 5 years except nonmelanoma skin cancer
  • Active infection requiring antibiotics
  • Uncontrolled seizure disorder or active neurological disease

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

Search/NCT00101192
NCT00101192Phase 2Completed

A Limited Access Phase II Trial of Cetuximab (C225, NSC #714692) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix

Gynecologic Oncology Group·interventional·Posted Jan 10, 2005·Updated Mar 17, 2014

In Brief

A Phase 2 clinical trial evaluating cetuximab and cisplatin for Cervical Cancer. Completed, enrolled 76 participants across 18 sites.

Detailed Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also help cisplatin work better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with cisplatin may be a better way to block tumor growth. PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin works in treating patients with advanced, persistent, or recurrent cervical cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2005
Enrollment StartSep 1, 2004
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 21.5 years ago

Interventions

cetuximabbiological

cisplatindrug