A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma

This study has been terminated.

(Too slow accrual)

Sponsor:

Collaborators:

Genentech

Eli Lilly and Company

Information provided by (Responsible Party):

Walter Stadler, University of Chicago

ClinicalTrials.gov Identifier:

NCT00523640

First received: August 30, 2007

Last updated: November 18, 2011

Last verified: November 2011

History of Changes

Results First Received: August 15, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Carcinoma, Renal Cell
Intervention:	Drug: combination of gemcitabine, capecitabine, and bevacizumab

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
30 patients were enrolled in the trial between March 2005 and May 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Combination of Gemcitabine, Capecitabine, and Bevacizumab	combination of gemcitabine, capecitabine, and bevacizumab

Participant Flow: Overall Study

	Combination of Gemcitabine, Capecitabine, and Bevacizumab
STARTED	30
COMPLETED	29 ^[1]
NOT COMPLETED	1
Death	1

[1]	1 patient died before starting treatment

Baseline Characteristics

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Reporting Groups

	Description
Combination of Gemcitabine, Capecitabine, and Bevacizumab	combination of gemcitabine, capecitabine, and bevacizumab

Baseline Measures

	Combination of Gemcitabine, Capecitabine, and Bevacizumab
Number of Participants [units: participants]	29
Age [units: years] Median ( Full Range )	58 ( 36 to 82 )
Gender [units: participants]
Female	5
Male	24
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	1
White	28
More than one race	0
Unknown or Not Reported	0
Region of Enrollment [units: participants]
United States	29
Performance Status ^[1] [units: participants]
0	5
1	23
2	1
Number of metastatic disease sites [units: participants]
1	2
2	6
3 or more	21
Tumor histology [units: participant]
Clear cell	23
Poorly differentiated/unclassified	6
Fuhrman grade ^[2] [units: participants]
1	0
2	2
3-4	21
Unknown	6
Prognostic risk group [units: participants]
Favorable	7
Intermediate	19
Poor	3
Prior therapy-Nephrectomy [units: participants]
Yes	24
No	5
Prior therapy-Radiotherapy [units: participants]
Yes	15
No	14
Prior therapy-Cytokine therapy [units: participants]
Yes	8
No	21
Prior therapy-Oral Vascular Endothelial Growth Factor (VEGF) receptor kinase inhibitor [units: participants]
Yes	20
No	9

[1]	ECOG performance status Scores on a scale Range 0-5, higher is worse
[2]	An important factor used to assess renal cell carcinoma is its Fuhrman grade. This scale refers to how closely the cancer cells look like normal kidney cells under a microscope. The Fuhrman grading system ranks tumor cells on a scale of 1 through 4 and is a prognostic scale. 1 represents the best prognosis and 4 the worst. Grade 1 tumor cells look similar to normal kidney cells. Grade 1 cancers typically grow and spread slowly and most often have a good prognosis. Grade 4 tumor cells look quite different from normal kidney cells and have a worse prognosis.

[1]

ECOG performance status Scores on a scale Range 0-5, higher is worse

[2]

An important factor used to assess renal cell carcinoma is its Fuhrman grade. This scale refers to how closely the cancer cells look like normal kidney cells under a microscope. The Fuhrman grading system ranks tumor cells on a scale of 1 through 4 and is a prognostic scale. 1 represents the best prognosis and 4 the worst. Grade 1 tumor cells look similar to normal kidney cells. Grade 1 cancers typically grow and spread slowly and most often have a good prognosis. Grade 4 tumor cells look quite different from normal kidney cells and have a worse prognosis.

Outcome Measures