CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 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/NCT00556049
NCT00556049Phase 2Completed
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Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma

Massachusetts General Hospital·interventional·Posted Nov 9, 2007·Updated Apr 21, 2016

In Brief

A Phase 2 clinical trial evaluating Gemcitabine and Sunitinib for Renal Cell Carcinoma and Neoplasm Metastases. Completed, enrolled 72 participants across 3 sites.

Detailed Summary

The purpose of this research study is to determine if the combination of sunitinib and gemcitabine is effective in treating patients with metastatic renal cell carcinoma. The safety of this combination will also be studied. Sunitinib is approved by the FDA for the treatment of renal cell carcinoma. However, some patients' cancers do not respond to treatment or stops responding after initially responding. Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of pancreatic cancer and several other cancers. It is not approved for the treatment of renal cell carcinoma. Previous research has suggested that combining gemcitabine with sunitinib may have some effectiveness in treating metastatic renal cell carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Carcinoma, Neoplasm Metastases
CountriesUnited States
CollaboratorsPfizer, Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2007
Enrollment StartDec 1, 2007
Primary CompletionDec 1, 2013
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 18.6 years ago

Interventions

Gemcitabinedrug

Intravenously on days 1 and 8 of each 21-day treatment cycle.

Sunitinibdrug

Orally on days 1-14 of each 21-day treatment cycle