Trial Outcomes & Findings for Sorafenib in Treating Patients With Locally Advanced or Metastatic Kidney Cancer (NCT NCT00727532)

Last Updated: 2019-05-03

Results Overview

Mean Difference in Apparent Diffusion Coefficient \[Time Frame: Baseline and Week 5\] To assess whether changes in the apparent diffusion coefficient (ADC) during neoadjuvant sorafenib treatment are detectable in locally advanced or metastatic kidney cancer. The ADC value will be calculated at baseline (within 28 days of initiating sorafenib) and Week 5, and the mean difference will be calculated. The percent change between this mean difference is reported. Week 5 ADC value minus baseline ADC value/divided by baseline ADC value was calculated for each participant. Apparent diffusion coefficient (ADC), obtained by measuring diffusion values at magnetic resonance imaging (MRI), is a measure of water mobility. Lower values correspond to tumor and higher values are consistent with cysts. With sorafenib therapy, the amount of free water may increase in a lesion due to necrosis, and as a result the ADC may increase in value.

Recruitment status

TERMINATED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

Baseline and week 5

Results posted on

2019-05-03

Participant Flow

Study was open to enrollment at Northwestern University beginning June 2008, and closed to enrollment in September 2012.

Participant milestones

Participant milestones
Measure	Sorafenib Sorafenib 400mg orally twice daily on days 1-28 sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sorafenib Sorafenib 400mg orally twice daily on days 1-28 sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Sorafenib in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib n=9 Participants Sorafenib 400mg orally twice daily on days 1-28
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants
Renal cell carcinoma Clinical Staging T1>3cm	0 participants n=5 Participants
Renal cell carcinoma Clinical Staging T2	0 participants n=5 Participants
Renal cell carcinoma Clinical Staging T3	8 participants n=5 Participants
Renal cell carcinoma Clinical Staging T4	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and week 5

Outcome measures

Outcome measures
Measure	Sorafenib n=7 Participants Sorafenib 400mg orally twice daily on days 1-28 sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment
Percentage Change in Difference in Apparent Diffusion Coefficient Between Baseline and Week 5	-7.57 Percent change Interval -59.0 to 49.4

PRIMARY outcome

Timeframe: Just prior to study week 5

Tumors were measured at baseline and approximately 29-34 days after completion of neoadjuvant treatment with sorafenib (just prior to surgery). Tumors were assessed by RECIST response criteria.

Outcome measures

Outcome measures
Measure	Sorafenib n=7 Participants Sorafenib 400mg orally twice daily on days 1-28 sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment
Change in Tumor Size From Baseline to Approximately 29-34 Days After Completion of Neoadjuvant Sorafenib Treatment	-5.34 percent change Interval -15.3 to 7.2

POST_HOC outcome

Timeframe: At time of surgery

Changes in MRI will be correlated with findings of necrosis. Amount of necrosis will be measured at baseline and at time of surgery. Percentage change for necrosis will be calculated from baseline and time of surgery.

Outcome measures

Outcome measures
Measure	Sorafenib n=7 Participants Sorafenib 400mg orally twice daily on days 1-28 sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment
Percentage Change of Necrosis From Baseline to Surgery	20.13 Percentage change Interval -38.32 to 92.92

Adverse Events

Sorafenib

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sorafenib n=9 participants at risk Sorafenib 400mg orally twice daily on days 1-28 sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment
Hepatobiliary disorders Pancreatitis	11.1% 1/9 • Number of events 1 • Adverse events assessed for 28 days prior to surgical resection
Skin and subcutaneous tissue disorders Hand-Foot Skin Reaction	11.1% 1/9 • Number of events 1 • Adverse events assessed for 28 days prior to surgical resection

Other adverse events

Other adverse events
Measure	Sorafenib n=9 participants at risk Sorafenib 400mg orally twice daily on days 1-28 sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment
Gastrointestinal disorders Mucositis/Stomatitis (functional symptomatic) - Oral Cavity	22.2% 2/9 • Adverse events assessed for 28 days prior to surgical resection
Investigations Elevated Transaminitis	22.2% 2/9 • Adverse events assessed for 28 days prior to surgical resection
Skin and subcutaneous tissue disorders Rash	55.6% 5/9 • Adverse events assessed for 28 days prior to surgical resection
Skin and subcutaneous tissue disorders Hand-Foot Skin reaction	44.4% 4/9 • Adverse events assessed for 28 days prior to surgical resection
Vascular disorders Hypertension	11.1% 1/9 • Adverse events assessed for 28 days prior to surgical resection
Skin and subcutaneous tissue disorders Dry Skin	11.1% 1/9 • Adverse events assessed for 28 days prior to surgical resection
Gastrointestinal disorders Nausea	33.3% 3/9 • Adverse events assessed for 28 days prior to surgical resection
Gastrointestinal disorders Diarrhea	22.2% 2/9 • Adverse events assessed for 28 days prior to surgical resection
Skin and subcutaneous tissue disorders Alopecia	11.1% 1/9 • Adverse events assessed for 28 days prior to surgical resection
Nervous system disorders Peripheral Sensory Neuropathy	11.1% 1/9 • Adverse events assessed for 28 days prior to surgical resection
General disorders Pain	11.1% 1/9 • Adverse events assessed for 28 days prior to surgical resection
General disorders Fatigue	22.2% 2/9 • Adverse events assessed for 28 days prior to surgical resection
Gastrointestinal disorders Anorexia	11.1% 1/9 • Adverse events assessed for 28 days prior to surgical resection
Investigations Elevated creatinine	22.2% 2/9 • Adverse events assessed for 28 days prior to surgical resection
General disorders Fever	22.2% 2/9 • Adverse events assessed for 28 days prior to surgical resection
Metabolism and nutrition disorders Hypocalcemia	11.1% 1/9 • Adverse events assessed for 28 days prior to surgical resection
Metabolism and nutrition disorders Hypokalemia	11.1% 1/9 • Adverse events assessed for 28 days prior to surgical resection
Metabolism and nutrition disorders Hyponatremia	33.3% 3/9 • Adverse events assessed for 28 days prior to surgical resection
Investigations Lymphopenia	11.1% 1/9 • Adverse events assessed for 28 days prior to surgical resection
Skin and subcutaneous tissue disorders Pruritis	11.1% 1/9 • Adverse events assessed for 28 days prior to surgical resection
Blood and lymphatic system disorders Anemia	11.1% 1/9 • Adverse events assessed for 28 days prior to surgical resection

Additional Information

Results Entry Administrator

Northwestern University

Phone: 312-695-1301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place