At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 41 enrolled

Drug / intervention

cisplatin +1 moredrug

Likely dose

cisplatin 30 mg/m2from 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/NCT00639769

NCT00639769Phase 2Completed

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Phase II Trial of Irinotecan Plus Cisplatin in Patients With Recurrent or Metastatic Squamous Carcinoma of the Head and Neck

Vanderbilt-Ingram Cancer Center·interventional·Posted Mar 20, 2008·Updated Sep 14, 2012

In Brief

A Phase 2 clinical trial evaluating cisplatin and irinotecan hydrochloride for Head and Neck Cancer. Completed, enrolled 41 participants across 8 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating recurrent or metastatic head and neck cancer.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHead and Neck Cancer

CountriesUnited States

CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2002

Primary CompletionMay 2007

First PostedMar 2008

Study CompletionJul 2008

TodayJul 2026

First PostedMar 20, 2008

Enrollment StartFeb 1, 2002

Primary CompletionMay 1, 2007

Study CompletionJul 1, 2008

TodayJul 2, 2026

Enrollment to primary: 5.3 yearsPosted 18.3 years ago

Interventions

cisplatindrug

Starting dose 30 mg/m2 Dose level -1 20 mg/m2

irinotecan hydrochloridedrug

50 mg/m2 IV over 60 minutes, plus Cisplatin 30mig/m2 IV, repeated weekly for two weeks. followed by a one-week rest. This 3-week schedule given two times to equal one 6-week cycle. Maximum of 6 cycles.