Trial Outcomes & Findings for Sorafenib, Gemcitabine, and Capecitabine in Treating Patients With Unresectable and/or Metastatic Kidney Cancer (NCT NCT00121251)
NCT ID: NCT00121251
Last Updated: 2021-04-06
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Up to 9 years
Results posted on
2021-04-06
Participant Flow
This study opened to enrollment in June 2005 and closed to enrollment September 2011. Patients were recruited from the inpatient and outpatient clinics at Weill Cornell Medical Center, Columbia University Medical Center, North Shore Hospital, New York University Hospital, Montefiore Medical Center, Mount Sinai Medical Center and others
Participant milestones
| Measure |
Sorafenib + Gemcitabine + Capecitabine
Patients receive sorafenib\* PO BID on days 1-21, gemcitabine IV over 30 minutes on days 1 and 8, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression.
Capecitabine: Given PO
Gemcitabine Hydrochloride: Given IV
Sorafenib Tosylate: Given PO
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sorafenib, Gemcitabine, and Capecitabine in Treating Patients With Unresectable and/or Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Sorafenib + Gemcitabine + Capecitabine
n=17 Participants
Patients receive sorafenib\* PO BID on days 1-21, gemcitabine IV over 30 minutes on days 1 and 8, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression.
Capecitabine: Given PO
Gemcitabine Hydrochloride: Given IV
Sorafenib Tosylate: Given PO
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
14 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
|
|
ECOG Performance Status
0 Normal Activity
|
4 Participants
n=5 Participants
|
|
ECOG Performance Status
1 Symptoms, but ambulatory. Restricted in strenuous activities
|
10 Participants
n=5 Participants
|
|
ECOG Performance Status
2 Capable of all self-care but unable to carry out any work activities. In bed <50% of the time
|
3 Participants
n=5 Participants
|
|
Histology
Papillary
|
6 Participants
n=5 Participants
|
|
Histology
Clear Cell
|
8 Participants
n=5 Participants
|
|
Histology
Sarcomatoid
|
1 Participants
n=5 Participants
|
|
Histology
Chromophobe
|
1 Participants
n=5 Participants
|
|
Histology
Unclassified
|
1 Participants
n=5 Participants
|
|
Site of Metastasis
Lung/Pleura
|
14 Participants
n=5 Participants
|
|
Site of Metastasis
Lymph Node
|
9 Participants
n=5 Participants
|
|
Site of Metastasis
Liver
|
3 Participants
n=5 Participants
|
|
Site of Metastasis
Bone
|
1 Participants
n=5 Participants
|
|
Site of Metastasis
Other Viscera
|
10 Participants
n=5 Participants
|
|
Site of Metastasis
2 or more sites
|
15 Participants
n=5 Participants
|
|
Previous Treatment
Nephrectomy
|
15 Participants
n=5 Participants
|
|
Previous Treatment
Cytokines
|
1 Participants
n=5 Participants
|
|
Previous Treatment
Sunitinib
|
1 Participants
n=5 Participants
|
|
MSK Classification
Favorable
|
5 Participants
n=5 Participants
|
|
MSK Classification
Intermediate
|
9 Participants
n=5 Participants
|
|
MSK Classification
Poor
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 9 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR
Outcome measures
| Measure |
Sorafenib + Gemcitabine + Capecitabine
n=17 Participants
Patients receive sorafenib\* PO BID on days 1-21, gemcitabine IV over 30 minutes on days 1 and 8, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression.
Capecitabine: Given PO
Gemcitabine Hydrochloride: Given IV
Sorafenib Tosylate: Given PO
|
|---|---|
|
Objective Response for BAY 43-9006 in Combination With Gemcitabine and Capecitabine Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)
|
5 Participants
|
SECONDARY outcome
Timeframe: From the time of the patient's initial best response (PR or CR) until documented progression, assessed up to 9 yearsPFS will be measured from the time of the patient's initial best response (PR or CR) until documented progression.
Outcome measures
| Measure |
Sorafenib + Gemcitabine + Capecitabine
n=17 Participants
Patients receive sorafenib\* PO BID on days 1-21, gemcitabine IV over 30 minutes on days 1 and 8, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression.
Capecitabine: Given PO
Gemcitabine Hydrochloride: Given IV
Sorafenib Tosylate: Given PO
|
|---|---|
|
Median Number of Months of Progression Free Survival (PFS)
|
5 Months
Interval 3.0 to 17.0
|
SECONDARY outcome
Timeframe: Up to 9 yearsOverall survival (OS) is defined as the time from start of treatment to death from any cause.
Outcome measures
| Measure |
Sorafenib + Gemcitabine + Capecitabine
n=17 Participants
Patients receive sorafenib\* PO BID on days 1-21, gemcitabine IV over 30 minutes on days 1 and 8, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression.
Capecitabine: Given PO
Gemcitabine Hydrochloride: Given IV
Sorafenib Tosylate: Given PO
|
|---|---|
|
Number of Participants Who Survived (Overall Survival)
|
6 Participants
|
Adverse Events
Sorafenib + Gemcitabine + Capecitabine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 11 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sorafenib + Gemcitabine + Capecitabine
n=17 participants at risk
Patients receive sorafenib\* PO BID on days 1-21, gemcitabine IV over 30 minutes on days 1 and 8, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression.
Capecitabine: Given PO
Gemcitabine Hydrochloride: Given IV
Sorafenib Tosylate: Given PO
|
|---|---|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
29.4%
5/17 • Number of events 5 • Up to 9 years
|
Additional Information
Cooperative Group Program Manager
Weill Cornell Medical College
Phone: 646-962-9377
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60