Trial Outcomes & Findings for Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma (NCT NCT00093782)

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Up to 8 years

Results posted on

2017-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Temsirolimus) Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR. temsirolimus: Given IV laboratory biomarker analysis: Correlative studies
Overall Study STARTED	36
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Temsirolimus) n=36 Participants Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR. temsirolimus: Given IV laboratory biomarker analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	58 years n=5 Participants
Gender Female	21 Participants n=5 Participants
Gender Male	15 Participants n=5 Participants
Region of Enrollment Canada	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 8 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Treatment (Temsirolimus) n=36 Participants Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR. temsirolimus: Given IV laboratory biomarker analysis: Correlative studies
Objective Tumor Response Rate (Defined as Partial or Complete Response as Defined by the RECIST Criteria)	2 participants

SECONDARY outcome

Timeframe: Up to 8 years

Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.

Outcome measures

Outcome measures
Measure	Treatment (Temsirolimus) n=36 Participants Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR. temsirolimus: Given IV laboratory biomarker analysis: Correlative studies
Stable Disease Rate Defined by RECIST Criteria	20 participants

SECONDARY outcome

Timeframe: 3

Population: Out of the 25 patients alive (in 2006 at time of publication)

Computed using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Treatment (Temsirolimus) n=25 Participants Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR. temsirolimus: Given IV laboratory biomarker analysis: Correlative studies
Median Survival Time	13.9 months Interval 2.8 to 22.6

SECONDARY outcome

Timeframe: 1 year

Population: Out of the 25 patients alive as of Jan 2006

Computed using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Treatment (Temsirolimus) n=25 Participants Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR. temsirolimus: Given IV laboratory biomarker analysis: Correlative studies
Survival Rate	71.5 percentage of participants Interval 57.1 to 89.5

SECONDARY outcome

Timeframe: 2 months

Population: Number of patients that had stable disease for 2 months

Assessed using RECIST criteria.Patients that had Stable disease for 2 months

Outcome measures

Outcome measures
Measure	Treatment (Temsirolimus) n=36 Participants Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR. temsirolimus: Given IV laboratory biomarker analysis: Correlative studies
Response and Stable Disease	20 patients

SECONDARY outcome

Timeframe: Duration of participants treatment upto 16wks (4cycles) of treatment

Safety and tolerability of treatment with Temsirolimus assessed using CTCAE v 3

Outcome measures

Outcome measures
Measure	Treatment (Temsirolimus) n=36 Participants Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR. temsirolimus: Given IV laboratory biomarker analysis: Correlative studies
Number of Temsirolimus Treatment Cycle Analyzed for Toxicity	213 treatment cycles

SECONDARY outcome

Timeframe: Up to 8 years

Population: At the time of publication, 5 patients were still on treatment and analysis was done on 31 patients

Outcome measures

Outcome measures
Measure	Treatment (Temsirolimus) n=31 Participants Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR. temsirolimus: Given IV laboratory biomarker analysis: Correlative studies
Time to Progression	6.0 months Interval 3.7 to Not reached

Adverse Events

Treatment (Temsirolimus)

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Temsirolimus) n=36 participants at risk Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR. temsirolimus: Given IV laboratory biomarker analysis: Correlative studies
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.8% 1/36
Vascular disorders Thromboembolic event	2.8% 1/36

Other adverse events

Other adverse events
Measure	Treatment (Temsirolimus) n=36 participants at risk Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR. temsirolimus: Given IV laboratory biomarker analysis: Correlative studies
General disorders Fatigue	77.8% 28/36
Metabolism and nutrition disorders Hyperglycemia	69.4% 25/36
Skin and subcutaneous tissue disorders rash / desquamation	63.9% 23/36

Additional Information

Dr. Lillian Siu

Princess Margaret Cancer Centre

Phone: 416-946-2911

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60