Trial Outcomes & Findings for Sunitinib in Treating Patients With Locally Advanced Bladder Cancer (NCT NCT00526656)

Last Updated: 2019-04-16

Results Overview

Number of participants who at the time of cystectomy, to have no evidence of tumor grossly and microscopically on routine Hematoxylin and Eosin stain (H\&E) (pathologic complete response or P0) will be defined as responders. All cases will be defined as responders (P0) or non-responders based on the presence of residual tumor. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since the treatment started.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

at 6 weeks

Results posted on

2019-04-16

Participant Flow

Eleven patients were entered into the trial between 9/07 and 12/09 from medical clinic. Two patients were considered ineligible and received no treatment.

Participant milestones

Participant milestones
Measure	Sunitinib Malate Drug sunitinib malate : 50mg PO daily 4 weeks on -2 weeks off
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sunitinib Malate Drug sunitinib malate : 50mg PO daily 4 weeks on -2 weeks off
Overall Study Death	1
Overall Study Refused surgery	1

Baseline Characteristics

Sunitinib in Treating Patients With Locally Advanced Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib Malate n=9 Participants Drug sunitinib malate : 50mg PO daily 4 weeks on -2 weeks off
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: at 6 weeks

Population: Participants who completed treatment and surgery

Outcome measures

Outcome measures
Measure	Sunitinib Malate n=7 Participants Drug sunitinib malate: 50mg PO daily 4 weeks on -2 weeks off
Pathologic Complete Response Rate of Sunitinib	0 Participants

SECONDARY outcome

Timeframe: following surgery at 6 weeks

Population: Participants who received treatment and surgery.

Determine if surgical morbidity was increased from time of last dose to time of surgery is defined as the number of subjects with increase non-ileus related morbidity due to treatment drug during the 2 week rest period.

Outcome measures

Outcome measures
Measure	Sunitinib Malate n=7 Participants Drug sunitinib malate: 50mg PO daily 4 weeks on -2 weeks off
Evaluate Treatment to Surgical Complication and Morbidity	0 Participants

SECONDARY outcome

Timeframe: at 4 weeks post-surgery

Population: Data not collected.

Time to progression will be measured as the time from when the patient started treatment to the time the patient is first recorded as having disease progression or the date of death if the patient dies due to causes other than disease progression.

Outcome measures

Outcome data not reported

Adverse Events

Sunitinib Malate

Serious events: 4 serious events

Other events: 9 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Sunitinib Malate n=9 participants at risk Drug sunitinib malate : 50mg PO daily 4 weeks on -2 weeks off
Blood and lymphatic system disorders Hemoglobin	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Blood and lymphatic system disorders Lymphopenia	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Blood and lymphatic system disorders Platelets	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
General disorders Death not associated with CTCAE term - Sudden death	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Renal and urinary disorders Hemorrhage, GU - Urethra	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Vascular disorders Hematoma	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Infections and infestations Infection with no more than Grade 2 ANC: Wound	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
General disorders Edema: limb	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Investigations Calcium, serum-low (hypocalcemia)	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Investigations Phosphate, serum-low (hypophosphatemia)	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.

Other adverse events

Other adverse events
Measure	Sunitinib Malate n=9 participants at risk Drug sunitinib malate : 50mg PO daily 4 weeks on -2 weeks off
Ear and labyrinth disorders Otitis, middle ear	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Blood and lymphatic system disorders Hemoglobin	66.7% 6/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Blood and lymphatic system disorders Leukocytes (total WBC)	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Blood and lymphatic system disorders Lymphopenia	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Blood and lymphatic system disorders Platelets	44.4% 4/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Cardiac disorders Hypertension	44.4% 4/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Investigations PTT (Partial Thromboplastin Time)	22.2% 2/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Blood and lymphatic system disorders Thrombotic microangiopathy	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
General disorders Fatigue (asthenia, lethargy, malaise)	44.4% 4/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
General disorders Rigors/chills	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
General disorders Weight loss	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Skin and subcutaneous tissue disorders Pruritus/itching	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	22.2% 2/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Skin and subcutaneous tissue disorders Wound complication, non-infectious	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Gastrointestinal disorders Anorexia	33.3% 3/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Gastrointestinal disorders Constipation	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Gastrointestinal disorders Diarrhea	33.3% 3/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Gastrointestinal disorders Gastritis (including bile reflux gastritis)	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Gastrointestinal disorders Heartburn/dyspepsia	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Gastrointestinal disorders Nausea	44.4% 4/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Gastrointestinal disorders Salivary gland changes/saliva	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Gastrointestinal disorders Taste alteration (dysgeusia)	44.4% 4/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Gastrointestinal disorders Vomiting	33.3% 3/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Skin and subcutaneous tissue disorders Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Renal and urinary disorders Hemorrhage, GU - Bladder	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Infections and infestations Colitis, infectious	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Infections and infestations Febrile neutropenia (fever of unknown origin >=38.5; no infection, ANC<1.0x10e9/L)	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
General disorders Edema: limb	22.2% 2/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Investigations Albumin, serum-low (hypoalbuminemia)	22.2% 2/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Investigations Alkaline phosphatase	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Investigations Calcium, serum-high (hypercalcemia)	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Investigations Calcium, serum-low (hypocalcemia)	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Investigations Creatinine	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Investigations Glucose, serum-high (hyperglycemia)	44.4% 4/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Investigations Phosphate, serum-low (hypophosphatemia)	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Investigations Potassium, serum-high (hyperkalemia)	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Investigations Sodium, serum-low (hyponatremia)	22.2% 2/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Nervous system disorders Mood alteration - Anxiety	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Nervous system disorders Neuropathy: sensory	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Gastrointestinal disorders Pain - Abdomen NOS	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Musculoskeletal and connective tissue disorders Pain - Back	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Musculoskeletal and connective tissue disorders Pain - Muscle	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Gastrointestinal disorders Pain - Oral cavity	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
General disorders Pain - Pain NOS	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Skin and subcutaneous tissue disorders Pain - Scalp	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Renal and urinary disorders Pain - Urethra	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Renal and urinary disorders Cystitis	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Renal and urinary disorders Urine color change	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Reproductive system and breast disorders Irregular menses (change from baseline)	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.
Vascular disorders Thrombosis/embolism (vascular access-related)	11.1% 1/9 • Adverse events (SAEs and AEs) collected from consent signed, while on treatment and followed 28 days after the last dose of treatment or until resolved or determined chronic or stable, whichever is later.

Additional Information

Jorge Garcia, MD

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Phone: 216-444-7774

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place