Trial Outcomes & Findings for Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma (NCT NCT00556049)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

Until disease progression

Results posted on

2016-04-21

Participant milestones
Measure	Treatment Sunitinib and gemcitabine Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle. Sunitinib: Orally on days 1-14 of each 21-day treatment cycle
Overall Study STARTED	72
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma

Baseline characteristics by cohort
Measure	Treatment n=72 Participants Sunitinib and gemcitabine Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle. Sunitinib: Orally on days 1-14 of each 21-day treatment cycle
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants

Timeframe: Until disease progression

Outcome measures
Measure	Treatment n=72 Participants Sunitinib and gemcitabine Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle. Sunitinib: Orally on days 1-14 of each 21-day treatment cycle
To Determine the Overall Response Rate of Combination Therapy With Gemcitabine and Sunitinib in Sarcomatoid and/or Poor-risk mRCC Patients as First Line Therapy.	25 percentage of participants

Serious events: 20 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events
Measure	Neutropenia n=72 participants at risk Sunitinib and gemcitabine Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle. Sunitinib: Orally on days 1-14 of each 21-day treatment cycle
Blood and lymphatic system disorders Neutropenia	27.8% 20/72

Other adverse events
Measure	Neutropenia n=72 participants at risk Sunitinib and gemcitabine Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle. Sunitinib: Orally on days 1-14 of each 21-day treatment cycle
Blood and lymphatic system disorders Neutropenia	27.8% 20/72

MGH Cancer Center

Phone: 617-726-1594