Trial Outcomes & Findings for Erlotinib in Treating Patients With Advanced Kidney Cancer (NCT NCT00045487)

Results Overview

Antitumor activity is measured with conventional techniques such as CT, MRI or X-ray. Scans are done at baseline then evaluated for response every 2 months. All tumor measurements must be recorded millimeters (or decimal fractions of centimeters).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

Disease progression or 52 weeks duration

Results posted on

2014-01-27

Participant Flow

Open to accrual on 6/25/2002, closed to accrual on 4/22/2004 at The University of Texas Health Science Center at the Cancer and Therapy Research Center

Participant milestones

Participant milestones
Measure	OSI-774 OSI-774, continuous daily oral administration of 150mg until disease progression or 52 weeks duration. Dose adjustment, reduction by increments of 50mg will be made for dose-limiting toxicity.
Overall Study STARTED	41
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Erlotinib in Treating Patients With Advanced Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OSI-774 n=41 Participants Once-daily oral administration for 4 weeks.
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	26 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants

PRIMARY outcome

Timeframe: Disease progression or 52 weeks duration

Population: Intent to treat analysis.

Antitumor activity is measured with conventional techniques such as CT, MRI or X-ray. Scans are done at baseline then evaluated for response every 2 months. All tumor measurements must be recorded millimeters (or decimal fractions of centimeters).

Outcome measures

Outcome measures
Measure	OSI-774 n=30 Participants Once-daily oral administration for 4 weeks.
Number of Patients With Ani-tumor Activity After Taking OSI-774.	7 participants 0

Adverse Events

OSI-774

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OSI-774 n=41 participants at risk Once-daily oral administration for 4 weeks.
Skin and subcutaneous tissue disorders Skin Rash	4.9% 2/41 • Number of events 2
Skin and subcutaneous tissue disorders Hand-Foot Syndrome	2.4% 1/41 • Number of events 1
Cardiac disorders PT Prolongation	2.4% 1/41 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Alain Mita, MD

University of Texas Health Science Center San Antonio

Phone: 210-450-5094

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place