Trial Outcomes & Findings for Study of Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer (NCT NCT01916109)
NCT ID: NCT01916109
Last Updated: 2016-02-12
Results Overview
The absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
1 year
Results posted on
2016-02-12
Participant Flow
Participant milestones
| Measure |
Gemcitabine, Carboplatin, and Panitumumab (GCaP)
Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Gemcitabine, Carboplatin, and Panitumumab (GCaP)
Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study of Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine, Carboplatin, and Panitumumab (GCaP)
n=4 Participants
Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.
Outcome measures
| Measure |
Gemcitabine, Carboplatin, and Panitumumab (GCaP)
n=3 Participants
Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
|
|---|---|
|
Pathologic Complete Response Rate (<pT0)
|
3 participants
|
Adverse Events
Gemcitabine, Carboplatin, and Panitumumab (GCaP)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine, Carboplatin, and Panitumumab (GCaP)
n=4 participants at risk
Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
|
|---|---|
|
General disorders
Wound dehiscence
|
25.0%
1/4 • Number of events 1
|
Other adverse events
| Measure |
Gemcitabine, Carboplatin, and Panitumumab (GCaP)
n=4 participants at risk
Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4
|
|
Ear and labyrinth disorders
Hearing impaired
|
25.0%
1/4
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
25.0%
1/4
|
|
Nervous system disorders
Tremor
|
25.0%
1/4
|
Additional Information
Dr. Dean Bajorin
Memorial Sloan Kettering Cancer Center
Phone: 646-422-4333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place