Trial Outcomes & Findings for Sorafenib in Treating Patients Who Are Undergoing Surgery for Metastatic Kidney Cancer (NCT NCT00126659)
NCT ID: NCT00126659
Last Updated: 2018-11-20
Results Overview
Response rate (participants with response/total number participants) where number of participants with response evaluated using international criteria proposed by (RECIST) Committee of: Complete Response: Disappearance all target lesions; Partial Response (PR): \> 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): \> 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or \> new lesions; Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.
TERMINATED
PHASE2
10 participants
Every 2 weeks during 4 week cycle
2018-11-20
Participant Flow
Recruitment Period: January 11, 2006 to July 12, 2007. All recruitment done at UT MD Anderson Cancer Center.
This trial was run at the same time as a competing trial and suffered from poor accrual. For that reason it was closed.
Participant milestones
| Measure |
Cytoreductive Nephrectomy Day 0
Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
|
Sorafenib + Cytoreductive Nephrectomy Day 8
Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
|
Sorafenib + Cytoreductive Nephrectomy Day 29
Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Cytoreductive Nephrectomy Day 0
Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
|
Sorafenib + Cytoreductive Nephrectomy Day 8
Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
|
Sorafenib + Cytoreductive Nephrectomy Day 29
Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
Baseline Characteristics
Sorafenib in Treating Patients Who Are Undergoing Surgery for Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Cytoreductive Nephrectomy Day 0
n=3 Participants
Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
|
Sorafenib + Cytoreductive Nephrectomy Day 8
n=3 Participants
Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
|
Sorafenib + Cytoreductive Nephrectomy Day 29
n=4 Participants
Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
10 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Every 2 weeks during 4 week cyclePopulation: Unable to assess response due to small sample size.
Response rate (participants with response/total number participants) where number of participants with response evaluated using international criteria proposed by (RECIST) Committee of: Complete Response: Disappearance all target lesions; Partial Response (PR): \> 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): \> 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or \> new lesions; Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Following 10 weeks of treatment, followed every 2 weeks or until disease progressionDuration of overall response is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), measured in days.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsThe number of participants surviving from baseline (treatment) to death due to any cause measured in days.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Following 10 weeks of treatment or until disease progressionTime, in weeks, after treatment until disease progresses. Repeat radiologic studies to evaluate disease progression or response after 10 weeks of BAY 43 9006 therapy.
Outcome measures
Outcome data not reported
Adverse Events
Sorafenib + Cytoreductive Nephrectomy
Serious adverse events
| Measure |
Sorafenib + Cytoreductive Nephrectomy
n=10 participants at risk
All participants received Sorafenib 400 mg orally mouth twice a day for a total of 10 weeks over the course of the study and had surgical procedure Cytoreductive Nephrectomy before treatment with Sorafenib or in between courses of Sorafenib
|
|---|---|
|
Blood and lymphatic system disorders
hyperuricemia
|
10.0%
1/10 • 1 year and 6 months
|
Other adverse events
| Measure |
Sorafenib + Cytoreductive Nephrectomy
n=10 participants at risk
All participants received Sorafenib 400 mg orally mouth twice a day for a total of 10 weeks over the course of the study and had surgical procedure Cytoreductive Nephrectomy before treatment with Sorafenib or in between courses of Sorafenib
|
|---|---|
|
General disorders
alopecia
|
20.0%
2/10 • 1 year and 6 months
|
|
Gastrointestinal disorders
anorexia
|
10.0%
1/10 • 1 year and 6 months
|
|
General disorders
cough
|
10.0%
1/10 • 1 year and 6 months
|
|
Metabolism and nutrition disorders
Creatinine
|
10.0%
1/10 • 1 year and 6 months
|
|
Gastrointestinal disorders
diarrhea
|
40.0%
4/10 • 1 year and 6 months
|
|
General disorders
dizziness
|
10.0%
1/10 • 1 year and 6 months
|
|
Gastrointestinal disorders
dysphagia
|
10.0%
1/10 • 1 year and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
10.0%
1/10 • 1 year and 6 months
|
|
General disorders
edema:head and neck
|
10.0%
1/10 • 1 year and 6 months
|
|
General disorders
fatigue
|
100.0%
10/10 • 1 year and 6 months
|
|
Skin and subcutaneous tissue disorders
hand foot syndrome
|
10.0%
1/10 • 1 year and 6 months
|
|
General disorders
hematoma
|
10.0%
1/10 • 1 year and 6 months
|
|
Blood and lymphatic system disorders
hemoglobin
|
40.0%
4/10 • 1 year and 6 months
|
|
Blood and lymphatic system disorders
hemoglobinuria
|
10.0%
1/10 • 1 year and 6 months
|
|
Blood and lymphatic system disorders
hypertension
|
20.0%
2/10 • 1 year and 6 months
|
|
Blood and lymphatic system disorders
hyperuricemia
|
10.0%
1/10 • 1 year and 6 months
|
|
Blood and lymphatic system disorders
hypoalbuminemia
|
10.0%
1/10 • 1 year and 6 months
|
|
Blood and lymphatic system disorders
hypomagnesemia
|
40.0%
4/10 • 1 year and 6 months
|
|
General disorders
hyponatremia
|
10.0%
1/10 • 1 year and 6 months
|
|
Blood and lymphatic system disorders
hypophosphatemia
|
20.0%
2/10 • 1 year and 6 months
|
|
Infections and infestations
infection (other),
|
10.0%
1/10 • 1 year and 6 months
|
|
Blood and lymphatic system disorders
leukocytes
|
20.0%
2/10 • 1 year and 6 months
|
|
Blood and lymphatic system disorders
lymphopenia
|
10.0%
1/10 • 1 year and 6 months
|
|
General disorders
mucositis
|
40.0%
4/10 • 1 year and 6 months
|
|
Gastrointestinal disorders
nausea
|
30.0%
3/10 • 1 year and 6 months
|
|
Blood and lymphatic system disorders
neutrophils (ANC)
|
10.0%
1/10 • 1 year and 6 months
|
|
Investigations
pain (chest/thorax)
|
10.0%
1/10 • 1 year and 6 months
|
|
Musculoskeletal and connective tissue disorders
pain (joint)
|
10.0%
1/10 • 1 year and 6 months
|
|
Blood and lymphatic system disorders
platelets
|
30.0%
3/10 • 1 year and 6 months
|
|
Renal and urinary disorders
proteinuria
|
10.0%
1/10 • 1 year and 6 months
|
|
Skin and subcutaneous tissue disorders
rash/desquamation
|
40.0%
4/10 • 1 year and 6 months
|
|
Investigations
secondary malignancy
|
10.0%
1/10 • 1 year and 6 months
|
|
Gastrointestinal disorders
vomiting
|
10.0%
1/10 • 1 year and 6 months
|
|
Eye disorders
watery eye
|
10.0%
1/10 • 1 year and 6 months
|
|
Gastrointestinal disorders
weight loss
|
10.0%
1/10 • 1 year and 6 months
|
|
Blood and lymphatic system disorders
Hypokalemia
|
10.0%
1/10 • 1 year and 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60