CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
cetuximab +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00316888
NCT00316888Phase 2Completed

Phase II Trial of Cetuximab Plus Cisplatin, 5- Fluorouracil and Radiation in Immunocompetent Patients With Anal Carcinoma

ECOG-ACRIN Cancer Research Group·interventional·Posted Apr 21, 2006·Updated Jun 29, 2023

In Brief

A Phase 2 clinical trial evaluating cetuximab, cisplatin, and 2 other interventions for Anal Cancer. Completed, enrolled 63 participants across 125 sites.

Detailed Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cetuximab may help cisplatin and fluorouracil work better by making tumor cells more sensitive to the drugs. It may also make tumor cells more sensitive to radiation therapy. Giving cetuximab together with chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin, fluorouracil, and radiation therapy works in treating immunocompetent patients with stage I (closed to accrual as of 11/3/2008), stage II, (some stage II closed to accrual as of 11/3/2008) or stage III anal cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 21, 2006
Enrollment StartFeb 28, 2007
Primary CompletionNov 1, 2015
Study CompletionAug 17, 2021
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 20.2 years ago

Interventions

cetuximabbiological

Given IV

cisplatindrug

Given IV

fluorouracildrug

Given IV

radiotherapyradiation

Given once daily 5 days a week for 5 weeks