Trial Outcomes & Findings for Dose Dense MVAC for Muscle Invasive Bladder Cancer (NCT NCT01031420)
NCT ID: NCT01031420
Last Updated: 2019-09-17
Results Overview
complete response rate (pT0), as defined by pathologic staging at cystectomy or ureterectomy, following neoadjuvant DD-MVAC chemotherapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Following completion of the 3rd/final cycle of chemotherapy (about week 9) by CT imaging and at time of surgery for pathologic response.
Results posted on
2019-09-17
Participant Flow
Participant milestones
| Measure |
Dose Dense MVAC
standard doses of MVAC given every 14 days x 3.
single arm dose dense MVAC: standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days.
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Dense MVAC for Muscle Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
Dose Dense MVAC
n=54 Participants
standard doses of MVAC given every 14 days x 3.
single arm dose dense MVAC: standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Following completion of the 3rd/final cycle of chemotherapy (about week 9) by CT imaging and at time of surgery for pathologic response.complete response rate (pT0), as defined by pathologic staging at cystectomy or ureterectomy, following neoadjuvant DD-MVAC chemotherapy.
Outcome measures
| Measure |
Dose Dense MVAC
n=44 Participants
standard doses of MVAC given every 14 days x 3.
single arm dose dense MVAC: standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days.
|
|---|---|
|
Percentage of Participants With Complete Response at Cystectomy or Ureterectomy Following Preoperative Dose Dense MVAC
|
38 percentage of total participants
Interval 23.0 to 53.0
|
SECONDARY outcome
Timeframe: Ongoing throughout treatment at each MD visit every 14 days.Population: Forty patients were evaluable for response as predefined in the protocol.
Defined by number of patients who complete all three cycles of treatment without dose reduction
Outcome measures
| Measure |
Dose Dense MVAC
n=40 Participants
standard doses of MVAC given every 14 days x 3.
single arm dose dense MVAC: standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days.
|
|---|---|
|
Toxicity Profile of Dose Dense MVAC Given in the Neoadjuvant Setting.
All three cycles of chemotherapy were completed
|
37 participants
|
|
Toxicity Profile of Dose Dense MVAC Given in the Neoadjuvant Setting.
Discontinued chemotherapy
|
3 participants
|
Adverse Events
Dose Dense MVAC
Serious events: 22 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Dense MVAC
n=40 participants at risk
standard doses of MVAC given every 14 days x 3.
single arm dose dense MVAC: standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.5%
3/40
|
|
General disorders
Fatigue
|
7.5%
3/40
|
|
Blood and lymphatic system disorders
Lymphocytopenia
|
7.5%
3/40
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
2/40
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40
|
|
Infections and infestations
Sepsis
|
2.5%
1/40
|
|
Renal and urinary disorders
proteinuria
|
2.5%
1/40
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.5%
1/40
|
|
Infections and infestations
Pharyngitis
|
2.5%
1/40
|
|
Gastrointestinal disorders
Mucositis
|
2.5%
1/40
|
|
Metabolism and nutrition disorders
Anorexia
|
2.5%
1/40
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.5%
1/40
|
|
Metabolism and nutrition disorders
hypokalemia
|
2.5%
1/40
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.5%
1/40
|
|
Metabolism and nutrition disorders
hyperkalemia
|
2.5%
1/40
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place