Trial Outcomes & Findings for 7-hydroxystaurosporine and Topotecan Hydrochloride in Treating Patients With Relapsed or Progressed Small Cell Lung Cancer (NCT NCT00098956)

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; Objective Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2018-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Topotecan Hydrochloride, UCN-01) Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR. topotecan hydrochloride: Given IV 7-hydroxystaurosporine: Given IV
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

7-hydroxystaurosporine and Topotecan Hydrochloride in Treating Patients With Relapsed or Progressed Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Topotecan Hydrochloride, UCN-01) n=19 Participants Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR. topotecan hydrochloride: Given IV 7-hydroxystaurosporine: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment Canada	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 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; Objective Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Treatment (Topotecan Hydrochloride, UCN-01) n=19 Participants Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR. topotecan hydrochloride: Given IV 7-hydroxystaurosporine: Given IV
Objective Response Rates (Complete and Partial) Evaluated Using RECIST Criteria	2 participants

SECONDARY outcome

Timeframe: Up to 5 years

Per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Treatment (Topotecan Hydrochloride, UCN-01) n=19 Participants Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR. topotecan hydrochloride: Given IV 7-hydroxystaurosporine: Given IV
Stable Disease Rate Evaluated Using RECIST Criteria	9 participants

SECONDARY outcome

Timeframe: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of enrollment to death or last contact, assessed up to 5 years

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	Treatment (Topotecan Hydrochloride, UCN-01) n=17 Participants Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR. topotecan hydrochloride: Given IV 7-hydroxystaurosporine: Given IV
Adverse Events, Graded Using the CTCAE Version 3.0	7 types of grade 3 / 4 toxicities reported

Adverse Events

Treatment (Topotecan Hydrochloride, UCN-01)

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Topotecan Hydrochloride, UCN-01) n=19 participants at risk Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR. topotecan hydrochloride: Given IV 7-hydroxystaurosporine: Given IV
General disorders Death NOS	5.3% 1/19 • Number of events 1
Cardiac disorders Sinus Tachycardia	5.3% 1/19 • Number of events 1
Cardiac disorders Cardiac disorder other	5.3% 1/19 • Number of events 1

Other adverse events

Other adverse events
Measure	Treatment (Topotecan Hydrochloride, UCN-01) n=19 participants at risk Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR. topotecan hydrochloride: Given IV 7-hydroxystaurosporine: Given IV
Investigations Neutrophil count decreased	68.4% 13/19 • Number of events 13
Investigations White blood cell decreased	73.7% 14/19 • Number of events 14
Investigations Platelet count decreased	31.6% 6/19 • Number of events 6

Additional Information

Dr. Glenwood Goss

The Ottawa Hospital

Phone: 613-737-7700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60