Trial Outcomes & Findings for Pemetrexed Plus Gemcitabine in Renal Cell Cancer (NCT NCT00491075)

Last Updated: 2013-04-24

Results Overview

Number of participants with complete or partial response. Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response: disappearance all target lesions; Partial Response: \>30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: \>20% increase sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or \> new lesions; Stable Disease: Insufficient shrinkage for partial response, or insufficient increase for progressive disease, reference smallest sum LD since treatment started.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Baseline to 8 weeks (after 4 cycles) protocol response at 16 weeks

Results posted on

2013-04-24

Participant Flow

Recruitment Period: December 13, 2005 through January 02, 2009. Participants were recruited from the UT MD Anderson's Genitourinary (GU) Cancer Center medical clinic.

Participant milestones

Participant milestones
Measure	Pemetrexed + Gemcitabine Pemetrexed 500 mg/m\^2 intravenous (IV) and Gemcitabine 1500 mg/m\^2 IV on Day 1.
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pemetrexed + Gemcitabine Pemetrexed 500 mg/m\^2 intravenous (IV) and Gemcitabine 1500 mg/m\^2 IV on Day 1.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1

Baseline Characteristics

Pemetrexed Plus Gemcitabine in Renal Cell Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pemetrexed + Gemcitabine n=16 Participants Pemetrexed 500 mg/m\^2 intravenous (IV) and Gemcitabine 1500 mg/m\^2 IV on Day 1.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	54 years STANDARD_DEVIATION 12.99 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 8 weeks (after 4 cycles) protocol response at 16 weeks

Population: One participant did not meet the required 16 week data end point and was excluded from the response evaluation and analysis.

Outcome measures

Outcome measures
Measure	Pemetrexed + Gemcitabine n=14 Participants Pemetrexed 500 mg/m\^2 intravenous (IV) and Gemcitabine 1500 mg/m\^2 IV on Day 1.
Overall Response	6.7 percentage of participants Interval 0.2 to 31.9

Adverse Events

Pemetrexed + Gemcitabine

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pemetrexed + Gemcitabine n=15 participants at risk Pemetrexed 500 mg/m\^2 intravenous (IV) and Gemcitabine 1500 mg/m\^2 IV on Day 1.
Vascular disorders thromboembolic event	6.7% 1/15 • Number of events 1 • 3 Years Of the 16 participants enrolled, one participant started the study but withdrew prior to receiving any treatment and is therefore excluded from adverse event reporting.

Other adverse events

Other adverse events
Measure	Pemetrexed + Gemcitabine n=15 participants at risk Pemetrexed 500 mg/m\^2 intravenous (IV) and Gemcitabine 1500 mg/m\^2 IV on Day 1.
Investigations white blood cell decreased	53.3% 8/15 • Number of events 8 • 3 Years Of the 16 participants enrolled, one participant started the study but withdrew prior to receiving any treatment and is therefore excluded from adverse event reporting.
Investigations neutrophil count decreased	53.3% 8/15 • Number of events 8 • 3 Years Of the 16 participants enrolled, one participant started the study but withdrew prior to receiving any treatment and is therefore excluded from adverse event reporting.
Blood and lymphatic system disorders anemia	13.3% 2/15 • Number of events 2 • 3 Years Of the 16 participants enrolled, one participant started the study but withdrew prior to receiving any treatment and is therefore excluded from adverse event reporting.
Investigations INR increased	6.7% 1/15 • Number of events 1 • 3 Years Of the 16 participants enrolled, one participant started the study but withdrew prior to receiving any treatment and is therefore excluded from adverse event reporting.
General disorders fatigue	40.0% 6/15 • Number of events 6 • 3 Years Of the 16 participants enrolled, one participant started the study but withdrew prior to receiving any treatment and is therefore excluded from adverse event reporting.
Renal and urinary disorders renal failure	13.3% 2/15 • Number of events 2 • 3 Years Of the 16 participants enrolled, one participant started the study but withdrew prior to receiving any treatment and is therefore excluded from adverse event reporting.
Metabolism and nutrition disorders hyperglycemia	6.7% 1/15 • Number of events 1 • 3 Years Of the 16 participants enrolled, one participant started the study but withdrew prior to receiving any treatment and is therefore excluded from adverse event reporting.
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 1 • 3 Years Of the 16 participants enrolled, one participant started the study but withdrew prior to receiving any treatment and is therefore excluded from adverse event reporting.
Gastrointestinal disorders vomiting	6.7% 1/15 • Number of events 1 • 3 Years Of the 16 participants enrolled, one participant started the study but withdrew prior to receiving any treatment and is therefore excluded from adverse event reporting.
Gastrointestinal disorders constipation	6.7% 1/15 • Number of events 1 • 3 Years Of the 16 participants enrolled, one participant started the study but withdrew prior to receiving any treatment and is therefore excluded from adverse event reporting.
Investigations alanine aminotransferase increased	6.7% 1/15 • Number of events 1 • 3 Years Of the 16 participants enrolled, one participant started the study but withdrew prior to receiving any treatment and is therefore excluded from adverse event reporting.
Infections and infestations aspartate aminotransferase	6.7% 1/15 • Number of events 1 • 3 Years Of the 16 participants enrolled, one participant started the study but withdrew prior to receiving any treatment and is therefore excluded from adverse event reporting.
General disorders fever (in the absence of neutropenia)	6.7% 1/15 • Number of events 1 • 3 Years Of the 16 participants enrolled, one participant started the study but withdrew prior to receiving any treatment and is therefore excluded from adverse event reporting.

Additional Information

Quality Assurance Specialist

U.T. MD Anderson Cancer Center

Phone: 713-792-2830

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place