CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 87 enrolled
Drug / intervention
Gemcitabine +1 moredrug
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/NCT01164228
NCT01164228Phase 2Completed

A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features

ECOG-ACRIN Cancer Research Group·interventional·Posted Jul 16, 2010·Updated Jun 15, 2023

In Brief

A Phase 2 clinical trial evaluating Gemcitabine and Sunitinib for Kidney Cancer. Completed, enrolled 87 participants across 99 sites.

Detailed Summary

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer. PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or without gemcitabine hydrochloride to see how well they work in treating patients with advanced kidney cancer that cannot be removed by surgery.

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2010
Enrollment StartSep 17, 2010
Primary CompletionMar 30, 2020
Study CompletionNov 3, 2021
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 16.0 years ago

Interventions

Gemcitabinedrug

Given IV

Sunitinibdrug

Given PO