Trial Outcomes & Findings for Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers (NCT NCT02392637)
NCT ID: NCT02392637
Last Updated: 2022-02-02
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
COMPLETED
PHASE2
62 participants
up to 3 years
2022-02-02
Participant Flow
Phase 2 clinical trial conducted at the University of Texas MD Anderson Cancer Center and the Mayo Clinic in Phoenix.
62 participants enrolled, 60 started treatment and 2 did not receive treatment (1) Progressive disease and (1) Withdrew consent.
Participant milestones
| Measure |
High Dosage
Gemcitabine 1000mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 125mg/m2 on days 1 \& 8 of a 21 day cycle.
|
Low Dosage
Gemcitabine 800mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 100mg/m2 on days 1 \& 8 of a 21 day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
28
|
|
Overall Study
COMPLETED
|
32
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Dosage
n=32 Participants
Gemcitabine 1000mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 125mg/m2 on days 1 \& 8 of a 21 day cycle.
|
Low Dosage
n=28 Participants
Gemcitabine 800mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 100mg/m2 on days 1 \& 8 of a 21 day cycle.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 11.1 • n=32 Participants
|
58.8 years
STANDARD_DEVIATION 11.1 • n=28 Participants
|
58.3 years
STANDARD_DEVIATION 11.1 • n=60 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=32 Participants
|
11 Participants
n=28 Participants
|
27 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=32 Participants
|
17 Participants
n=28 Participants
|
33 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
28 participants
n=28 Participants
|
60 participants
n=60 Participants
|
|
Tumor Type
Intrahepatic cholangiocarcinoma (IHCC)
|
24 Participants
n=32 Participants
|
14 Participants
n=28 Participants
|
38 Participants
n=60 Participants
|
|
Tumor Type
Extrahepatic cholangiocarcinoma (EHCC)
|
4 Participants
n=32 Participants
|
5 Participants
n=28 Participants
|
9 Participants
n=60 Participants
|
|
Tumor Type
Gallbladder Cancer (GBC)
|
4 Participants
n=32 Participants
|
9 Participants
n=28 Participants
|
13 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: up to 3 yearsPopulation: 3 participants are not included due to 2 Discontinued during cycle 1 (adverse event) and 1 Refused treatment following cycle 1 (patient choice). The analysis for PFS were calculated for the total treated population that received both high and low dosage.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
High Dosage
n=31 Participants
Gemcitabine 1000mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 125mg/m2 on days 1 \& 8 of a 21 day cycle
|
Low Dosage
n=26 Participants
Gemcitabine 800mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 100mg/m2 on days 1 \& 8 of a 21 day cycle.
|
|---|---|---|
|
Median Progression Free Survival (PFS)
|
11.4 months
Interval 6.0 to 15.6
|
14.9 months
Interval 3.8 to
Not estimable due to limited number of events
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: 3 participants are not included due to they were lost to follow up.
The Kaplan-Meier method was used to estimate OS, with surviving patients censored at the time of surgery or at last known follow-up.
Outcome measures
| Measure |
High Dosage
n=31 Participants
Gemcitabine 1000mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 125mg/m2 on days 1 \& 8 of a 21 day cycle
|
Low Dosage
n=26 Participants
Gemcitabine 800mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 100mg/m2 on days 1 \& 8 of a 21 day cycle.
|
|---|---|---|
|
Median Overall Survival (OS)
|
19.5 months
Interval 10.0 to
Not estimable due to limited number of events.
|
15.7 months
Interval 8.7 to
Not estimable due to limited number of events.
|
SECONDARY outcome
Timeframe: Up to 2 yearsPer Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1.14) 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
| Measure |
High Dosage
n=32 Participants
Gemcitabine 1000mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 125mg/m2 on days 1 \& 8 of a 21 day cycle
|
Low Dosage
n=28 Participants
Gemcitabine 800mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 100mg/m2 on days 1 \& 8 of a 21 day cycle.
|
|---|---|---|
|
Number of Participants With Treatment Response Rate
Unknown
|
4 Participants
|
5 Participants
|
|
Number of Participants With Treatment Response Rate
Disease Control Rate(DCR)
|
25 Participants
|
18 Participants
|
|
Number of Participants With Treatment Response Rate
Complete Response(CR)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Response Rate
Partial Response (PR)
|
14 Participants
|
9 Participants
|
|
Number of Participants With Treatment Response Rate
Stable Disease(SD)
|
11 Participants
|
9 Participants
|
|
Number of Participants With Treatment Response Rate
Progressive Disease(PD)
|
3 Participants
|
5 Participants
|
Adverse Events
High Dose
Low Dose
Serious adverse events
| Measure |
High Dose
n=32 participants at risk
Gemcitabine 1000mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 125mg/m2 on days 1 \& 8 of a 21 day cycle.
|
Low Dose
n=28 participants at risk
Gemcitabine 800mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 100mg/m2 on days 1 \& 8 of a 21 day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
15.6%
5/32 • up to 3 years
|
3.6%
1/28 • up to 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
1/32 • up to 3 years
|
3.6%
1/28 • up to 3 years
|
Other adverse events
| Measure |
High Dose
n=32 participants at risk
Gemcitabine 1000mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 125mg/m2 on days 1 \& 8 of a 21 day cycle.
|
Low Dose
n=28 participants at risk
Gemcitabine 800mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 100mg/m2 on days 1 \& 8 of a 21 day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
8/32 • up to 3 years
|
32.1%
9/28 • up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
18.8%
6/32 • up to 3 years
|
10.7%
3/28 • up to 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
4/32 • up to 3 years
|
3.6%
1/28 • up to 3 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.1%
1/32 • up to 3 years
|
7.1%
2/28 • up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • up to 3 years
|
3.6%
1/28 • up to 3 years
|
|
Blood and lymphatic system disorders
Elevated ALP
|
3.1%
1/32 • up to 3 years
|
3.6%
1/28 • up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
2/32 • up to 3 years
|
0.00%
0/28 • up to 3 years
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/32 • up to 3 years
|
3.6%
1/28 • up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32 • up to 3 years
|
0.00%
0/28 • up to 3 years
|
|
Renal and urinary disorders
Cystitis
|
3.1%
1/32 • up to 3 years
|
0.00%
0/28 • up to 3 years
|
|
Blood and lymphatic system disorders
Elevated AST
|
3.1%
1/32 • up to 3 years
|
0.00%
0/28 • up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/32 • up to 3 years
|
3.6%
1/28 • up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.1%
1/32 • up to 3 years
|
0.00%
0/28 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
3.1%
1/32 • up to 3 years
|
0.00%
0/28 • up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • up to 3 years
|
0.00%
0/28 • up to 3 years
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/32 • up to 3 years
|
3.6%
1/28 • up to 3 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/32 • up to 3 years
|
3.6%
1/28 • up to 3 years
|
|
Vascular disorders
Thromboembolic event
|
3.1%
1/32 • up to 3 years
|
0.00%
0/28 • up to 3 years
|
Additional Information
Dr. Milind Javle, Professor, GI Medical Oncology
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place