Trial Outcomes & Findings for A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma (NCT NCT00523640)
NCT ID: NCT00523640
Last Updated: 2014-02-11
Results Overview
Per RECIST Criteria (V1.0) using standard cross-sectional CT scanning: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Response (R)= CR + PR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
12 weeks
Results posted on
2014-02-11
Participant Flow
30 patients were enrolled in the trial between March 2005 and May 2008
Participant milestones
| Measure |
Combination of Gemcitabine, Capecitabine, and Bevacizumab
combination of gemcitabine, capecitabine, and bevacizumab
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Combination of Gemcitabine, Capecitabine, and Bevacizumab
combination of gemcitabine, capecitabine, and bevacizumab
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Combination of Gemcitabine, Capecitabine, and Bevacizumab
n=29 Participants
combination of gemcitabine, capecitabine, and bevacizumab
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
|
Performance Status
0
|
5 participants
n=5 Participants
|
|
Performance Status
1
|
23 participants
n=5 Participants
|
|
Performance Status
2
|
1 participants
n=5 Participants
|
|
Number of metastatic disease sites
1
|
2 participants
n=5 Participants
|
|
Number of metastatic disease sites
2
|
6 participants
n=5 Participants
|
|
Number of metastatic disease sites
3 or more
|
21 participants
n=5 Participants
|
|
Tumor histology
Clear cell
|
23 participant
n=5 Participants
|
|
Tumor histology
Poorly differentiated/unclassified
|
6 participant
n=5 Participants
|
|
Fuhrman grade
1
|
0 participants
n=5 Participants
|
|
Fuhrman grade
2
|
2 participants
n=5 Participants
|
|
Fuhrman grade
3-4
|
21 participants
n=5 Participants
|
|
Fuhrman grade
Unknown
|
6 participants
n=5 Participants
|
|
Prognostic risk group
Favorable
|
7 participants
n=5 Participants
|
|
Prognostic risk group
Intermediate
|
19 participants
n=5 Participants
|
|
Prognostic risk group
Poor
|
3 participants
n=5 Participants
|
|
Prior therapy-Nephrectomy
Yes
|
24 participants
n=5 Participants
|
|
Prior therapy-Nephrectomy
No
|
5 participants
n=5 Participants
|
|
Prior therapy-Radiotherapy
Yes
|
15 participants
n=5 Participants
|
|
Prior therapy-Radiotherapy
No
|
14 participants
n=5 Participants
|
|
Prior therapy-Cytokine therapy
Yes
|
8 participants
n=5 Participants
|
|
Prior therapy-Cytokine therapy
No
|
21 participants
n=5 Participants
|
|
Prior therapy-Oral Vascular Endothelial Growth Factor (VEGF) receptor kinase inhibitor
Yes
|
20 participants
n=5 Participants
|
|
Prior therapy-Oral Vascular Endothelial Growth Factor (VEGF) receptor kinase inhibitor
No
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPer RECIST Criteria (V1.0) using standard cross-sectional CT scanning: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Response (R)= CR + PR.
Outcome measures
| Measure |
Combination of Gemcitabine, Capecitabine, and Bevacizumab
n=29 Participants
combination of gemcitabine, capecitabine, and bevacizumab
|
|---|---|
|
Objective Response Rate
|
0.24 proportion
Interval 0.1 to 0.44
|
PRIMARY outcome
Timeframe: 60 monthsProgression is defined as a measurable increase in the sum of longest diameters of all target lesions, or unequivocable progression of non-target lesions, or the appearance of new lesions, since baseline
Outcome measures
| Measure |
Combination of Gemcitabine, Capecitabine, and Bevacizumab
n=29 Participants
combination of gemcitabine, capecitabine, and bevacizumab
|
|---|---|
|
Progression-free Survival
|
5.3 months
Interval 3.9 to 9.9
|
SECONDARY outcome
Timeframe: 60 monthsTime from enrollment until death from any cause.
Outcome measures
| Measure |
Combination of Gemcitabine, Capecitabine, and Bevacizumab
n=29 Participants
combination of gemcitabine, capecitabine, and bevacizumab
|
|---|---|
|
Overall Survival
|
9.8 months
Interval 6.2 to 14.9
|
Adverse Events
Combination of Gemcitabine, Capecitabine, and Bevacizumab
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combination of Gemcitabine, Capecitabine, and Bevacizumab
n=29 participants at risk
combination of gemcitabine, capecitabine, and bevacizumab
|
|---|---|
|
Nervous system disorders
Seizure
|
3.4%
1/29 • Adverse events were monitored over the course of treatment
Reported are numbers of patients with grade 3 or higher toxicity National Cancer Institute Common Toxicity Criteria (version 3.0) were used to assess and report adverse events
|
|
Infections and infestations
Sepsis
|
3.4%
1/29 • Adverse events were monitored over the course of treatment
Reported are numbers of patients with grade 3 or higher toxicity National Cancer Institute Common Toxicity Criteria (version 3.0) were used to assess and report adverse events
|
|
Gastrointestinal disorders
Bowel perforation
|
3.4%
1/29 • Adverse events were monitored over the course of treatment
Reported are numbers of patients with grade 3 or higher toxicity National Cancer Institute Common Toxicity Criteria (version 3.0) were used to assess and report adverse events
|
|
Blood and lymphatic system disorders
Pulmonary Embolism/Deep Vein Thrombosis
|
10.3%
3/29 • Adverse events were monitored over the course of treatment
Reported are numbers of patients with grade 3 or higher toxicity National Cancer Institute Common Toxicity Criteria (version 3.0) were used to assess and report adverse events
|
Other adverse events
| Measure |
Combination of Gemcitabine, Capecitabine, and Bevacizumab
n=29 participants at risk
combination of gemcitabine, capecitabine, and bevacizumab
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
17.2%
5/29 • Adverse events were monitored over the course of treatment
Reported are numbers of patients with grade 3 or higher toxicity National Cancer Institute Common Toxicity Criteria (version 3.0) were used to assess and report adverse events
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.0%
9/29 • Adverse events were monitored over the course of treatment
Reported are numbers of patients with grade 3 or higher toxicity National Cancer Institute Common Toxicity Criteria (version 3.0) were used to assess and report adverse events
|
|
Blood and lymphatic system disorders
Anemia
|
13.8%
4/29 • Adverse events were monitored over the course of treatment
Reported are numbers of patients with grade 3 or higher toxicity National Cancer Institute Common Toxicity Criteria (version 3.0) were used to assess and report adverse events
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
6.9%
2/29 • Adverse events were monitored over the course of treatment
Reported are numbers of patients with grade 3 or higher toxicity National Cancer Institute Common Toxicity Criteria (version 3.0) were used to assess and report adverse events
|
|
Skin and subcutaneous tissue disorders
Hand foot syndrome
|
6.9%
2/29 • Adverse events were monitored over the course of treatment
Reported are numbers of patients with grade 3 or higher toxicity National Cancer Institute Common Toxicity Criteria (version 3.0) were used to assess and report adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.9%
2/29 • Adverse events were monitored over the course of treatment
Reported are numbers of patients with grade 3 or higher toxicity National Cancer Institute Common Toxicity Criteria (version 3.0) were used to assess and report adverse events
|
|
General disorders
Fatigue
|
20.7%
6/29 • Adverse events were monitored over the course of treatment
Reported are numbers of patients with grade 3 or higher toxicity National Cancer Institute Common Toxicity Criteria (version 3.0) were used to assess and report adverse events
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • Adverse events were monitored over the course of treatment
Reported are numbers of patients with grade 3 or higher toxicity National Cancer Institute Common Toxicity Criteria (version 3.0) were used to assess and report adverse events
|
|
Gastrointestinal disorders
Emesis
|
6.9%
2/29 • Adverse events were monitored over the course of treatment
Reported are numbers of patients with grade 3 or higher toxicity National Cancer Institute Common Toxicity Criteria (version 3.0) were used to assess and report adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place