Trial Outcomes & Findings for Gemcitabine and Pazopanib in Chemotherapy Naïve Patients With Advanced/Metastatic Urothelial Carcinoma Ineligible for Cisplatin-based Chemotherapy (NCT NCT01622660)

Last Updated: 2017-08-22

Results Overview

Progression Free Survival will be calculated from the start of treatment until progressive disease or death. Patients who die before documented progression will be considered failures at their time of death. If the patient did not progress or die, the patient will be censored on the date of last follow-up. Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Measurable lesions: lesions that can be accurately measured in at least one dimension with longest diameter ≥ 10 mm by clinical exam or with spiral CT scan or MRI (no less than double the slice thickness and a minimum of 10mm). Malignant lymph nodes must be 15 mm in the short axis when assessed by spiral CT scan to be considered measurable. Non-measurable lesions: all other lesions (or sites of disease) including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm u

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

2 years

Results posted on

2017-08-22

Participant Flow

Protocol Open to Accrual 06/14/2012 Protocol Closed to Accrual 02/05/2014 Primary Completion Date 02/03/2016 Recruitment Location is the medical clinic

Participant milestones

Participant milestones
Measure	Gemcitabine and Pazopanib Chemotherapy naïve participants with advanced/metastatic urothelial carcinoma ineligible for Cisplatin-based chemotherapy
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Gemcitabine and Pazopanib Chemotherapy naïve participants with advanced/metastatic urothelial carcinoma ineligible for Cisplatin-based chemotherapy
Overall Study Adverse Event	1

Baseline Characteristics

Gemcitabine and Pazopanib in Chemotherapy Naïve Patients With Advanced/Metastatic Urothelial Carcinoma Ineligible for Cisplatin-based Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine and Pazopanib n=2 Participants This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy. Gemcitabine and Pazopanib: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days). Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	70.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 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	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	0 Participants n=5 Participants
Race (NIH/OMB) White	2 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	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Gemcitabine and Pazopanib n=1 Participants This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy. Gemcitabine and Pazopanib: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days). Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles.
Progression Free Survival (PFS)	184 days

Adverse Events

Gemcitabine and Pazopanib

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine and Pazopanib n=2 participants at risk This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy. Gemcitabine and Pazopanib: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days). Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles.
Hepatobiliary disorders Elevated ALT with concomitant elevation in Bilirubin	50.0% 1/2 • Number of events 1 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.

Other adverse events

Other adverse events
Measure	Gemcitabine and Pazopanib n=2 participants at risk This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy. Gemcitabine and Pazopanib: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days). Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles.
Hepatobiliary disorders Elevated ALT	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Blood and lymphatic system disorders Lymphopenia	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Hepatobiliary disorders Elevated Alkaline Phosphatase	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Blood and lymphatic system disorders Anemia	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Hepatobiliary disorders Elevated AST	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Hepatobiliary disorders Blood Bilrubin Increased	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Gastrointestinal disorders Constipation	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Gastrointestinal disorders Diarrhea	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Nervous system disorders Dysgeusia	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
General disorders Fatigue	100.0% 2/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
General disorders Fever	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Gastrointestinal disorders Gastroesophageal reflux disorder	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Gastrointestinal disorders Gastrointestinal disorders, other	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Nervous system disorders Headache	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Respiratory, thoracic and mediastinal disorders Hiccups	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Metabolism and nutrition disorders Hypocalcemia	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Metabolism and nutrition disorders Hyponatremia	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Investigations INR increased	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Gastrointestinal disorders Mucositis oral	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Gastrointestinal disorders Nausea	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Blood and lymphatic system disorders Neutropenia	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Nervous system disorders Peripheral sensory neuropathy	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Renal and urinary disorders Urinary retention	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Gastrointestinal disorders Vomiting	50.0% 1/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.
Investigations Leukopenia	100.0% 2/2 • 0.8 months to 6.3 months Adverse event data were collected for the duration of treatment. For Patient 001 this was 0.8 months. For Patient 002 this was 6.3 months.

Additional Information

Dr. Dean Bajorin

Memorial Sloan Kettering Cancer Center

Phone: 646-422-4333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place