Trial Outcomes & Findings for Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer (NCT NCT00089102)

NCT ID: NCT00089102

Last Updated: 2018-07-16

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: From registration until time of complete response or partial response
• Results posted on: 2018-07-16

Participant Flow

Participant milestones

Measure	Gemcitabine + Irinotecan gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle irinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer

Baseline characteristics by cohort

Measure	Gemcitabine + Irinotecan n=9 Participants gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle irinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle
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	1 Participants n=5 Participants
Sex: Female, Male Male	8 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	3 Participants n=5 Participants
Race (NIH/OMB) White	6 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	9 participants n=5 Participants

PRIMARY outcome

Timeframe: From registration until time of complete response or partial response

Population: All patients treated on study who underwent a response assessment

Outcome measures

Measure	Gemcitabine + Irinotecan n=7 Participants gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle irinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle
Response Proportion Complete response	1 Participants
Response Proportion Partial Response	4 Participants
Response Proportion Stable or Progressive Disease	2 Participants

SECONDARY outcome

Timeframe: From registration until disease progression among patients who had at least a partial response

Population: Data is not available for this endpoint was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the day of first dose until the end of study, for an average of 6 months

Outcome measures

Measure	Gemcitabine + Irinotecan n=9 Participants gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle irinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle
Number of Participants Who Experienced SAEs on Study Number of patients who did not experience an SAE	5 Participants
Number of Participants Who Experienced SAEs on Study Number of patients who experienced an SAE	4 Participants

SECONDARY outcome

Timeframe: Time between registration and disease progression or death, whichever comes first.

Population: Data for this endpoint was not collected

Outcome measures

Outcome data not reported

Adverse Events

Gemcitabine + Irinotecan

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Gemcitabine + Irinotecan n=9 participants at risk gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle irinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle
Respiratory, thoracic and mediastinal disorders left pleural effusion	11.1% 1/9 • Number of events 1 • From day 1 until end of study visit, an average of 6 months Data for adverse events (non-serious) was not collected.
Respiratory, thoracic and mediastinal disorders pneumonitis	11.1% 1/9 • Number of events 1 • From day 1 until end of study visit, an average of 6 months Data for adverse events (non-serious) was not collected.
General disorders cerebrovascular accident	11.1% 1/9 • Number of events 1 • From day 1 until end of study visit, an average of 6 months Data for adverse events (non-serious) was not collected.
Blood and lymphatic system disorders neutropenia	11.1% 1/9 • Number of events 1 • From day 1 until end of study visit, an average of 6 months Data for adverse events (non-serious) was not collected.

Other adverse events

Adverse event data not reported

Additional Information

Kate Anderton

Medical University of South Carolina

Phone: 843-792-2708

Email: anderton@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place