Trial Outcomes & Findings for Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer (NCT NCT00103194)

Last Updated: 2014-09-30

Results Overview

PSA response is defined as either complete response (CR) or partial response (PR) observed at any time during the entire measurement time period. CR: In patients treated with prior radical prostatectomy, a PSA \< 0.2 ng/mL confirmed by a repeat PSA at least one month apart was considered a complete biochemical response. In patients treated with radiation therapy only, a PSA \< 1 ng/mL on three separate occasions taken at least one month apart was considered a complete biochemical response. PR: A reduction in PSA by \> 50% from baseline, confirmed by repeat PSA 1 month later.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Results posted on

2014-09-30

Participant Flow

Participants were recruited from ECOG member institutions between September 29, 2005 and July 5, 2006.

Participant milestones

Participant milestones
Measure	GW572016 (Lapatinib) GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
Overall Study STARTED	49
Overall Study Treated	49
Overall Study Eligible	35
Overall Study Eligible and Treated	35
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GW572016 (Lapatinib) n=35 Participants GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
Age, Continuous	65 years n=113 Participants
Sex: Female, Male Female	0 Participants n=113 Participants
Sex: Female, Male Male	35 Participants n=113 Participants

PRIMARY outcome

Timeframe: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Population: Eligible patients who started protocol treatment

Outcome measures

Outcome measures
Measure	GW572016 (Lapatinib) n=35 Participants GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level Stable Disease	28 participants
Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level Progression	4 participants
Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level Unevaluable	3 participants
Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level Response	0 participants

SECONDARY outcome

Timeframe: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually, for 5 years

Population: One patient who withdrew from study after receiving 4 days of treatment and did not have any follow-up PSA measurements was excluded from this analysis, so the number of participants analyzed is 34.

PSA was evaluated every cycle while on treatment. PSA test results show the level of PSA detected in the blood. These results were reported as nanograms of PSA per milliliter (ng/mL) of blood. PSA slope is the change in PSA level over time. A sharp rise in the PSA level raises the suspicion of cancer and may indicate a fast-growing cancer.

Outcome measures

Outcome measures
Measure	GW572016 (Lapatinib) n=34 Participants GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
The Change in PSA Slope With GW572016 (Lapatinib) Post-treatment PSA slope	0.13 log (PSA)/month Standard Error 0.017
The Change in PSA Slope With GW572016 (Lapatinib) Pre-treatment PSA slope	0.19 log (PSA)/month Standard Error 0.019

SECONDARY outcome

Timeframe: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Population: Eligible patients who started treatment.

Proportion of patients who are living with a disease that does not get worse at 2 years from registration based on Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	GW572016 (Lapatinib) n=35 Participants GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
Progression-free Survival Rate at 2 Years	16.0 percentage of participants Interval 6.5 to 29.1

SECONDARY outcome

Timeframe: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Population: Eligible patients who started treatment.

The association between EGFR (epidermal growth factor receptor) expression levels and the length of time during and after treatment in which a patient is living with a disease that does not get worse.

Outcome measures

Outcome measures
Measure	GW572016 (Lapatinib) n=35 Participants GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
Relationship Between Progression-free Survival and EGFR Expression Levels High EGFR	17.4 months Interval 4.7 to 20.9
Relationship Between Progression-free Survival and EGFR Expression Levels Low EGFR	6.0 months Interval 3.0 to 12.4

Adverse Events

GW572016 (Lapatinib)

Serious events: 4 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GW572016 (Lapatinib) n=49 participants at risk GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
General disorders Fatigue	2.0% 1/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations AST Increased	2.0% 1/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations Bilirubin Increased	4.1% 2/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.

Other adverse events

Other adverse events
Measure	GW572016 (Lapatinib) n=49 participants at risk GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
Blood and lymphatic system disorders Anemia	8.2% 4/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
General disorders Fatigue	46.9% 23/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Psychiatric disorders Insomnia	8.2% 4/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Dry Skin	12.2% 6/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Vascular disorders Flushing	6.1% 3/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Alopecia	6.1% 3/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Nail Changes	12.2% 6/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Pruritus/Itching	12.2% 6/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Rash/Desquamation	18.4% 9/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Rash: Acne/Acneiform	71.4% 35/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Skin- Other	10.2% 5/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Anorexia	8.2% 4/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Constipation	6.1% 3/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Diarrhea w/o Prior Colostomy	69.4% 34/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Flatulence	6.1% 3/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Dyspepsia	10.2% 5/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Nausea	6.1% 3/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Nose, Hemorrhage	6.1% 3/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations ALT Increased	18.4% 9/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations AST Increased	14.3% 7/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations Bilirubin Increased	18.4% 9/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hyperglycemia	8.2% 4/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Nervous system disorders Neuropathy-Sensory	8.2% 4/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Abdominal Pain	10.2% 5/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Nervous system disorders Headache	8.2% 4/49 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.

Additional Information

"Study Statistician"

"ECOG Statistical Office"

Phone: 617-632-3012

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60