Trial Outcomes & Findings for Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer (NCT NCT01308840)
NCT ID: NCT01308840
Last Updated: 2016-08-17
Results Overview
Tumor measurement - same imaging modality used in pre-treatment evaluation - include radiological examination of all areas with affected disease. For pretreatment and at the end of cycle 2 CT scans (chest/abdomen/pelvis) will be used. For all subsequent cycles, CT of chest/abdomen/pelvis will be used every 8 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
end of cycle 2 of treatment
Results posted on
2016-08-17
Participant Flow
38 participants were screened.
5 subjects were not eligible to enroll. 2 participants did not receive the intervention.
Participant milestones
| Measure |
Panitumumab
Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Panitumumab: Day 1 and 15 = 6 mg/kg IV
oxaliplatin: Days 1 and 15 = 85mg/m2 IV
gemcitabine: Days 1 and 15 = 1000 mg/m2 IV
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer
Baseline characteristics by cohort
| Measure |
Panitumumab
n=31 Participants
Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Panitumumab: Day 1 and 15 = 6 mg/kg IV
oxaliplatin: Days 1 and 15 = 85mg/m2 IV
gemcitabine: Days 1 and 15 = 1000 mg/m2 IV
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance status
0
|
10 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance status
1
|
21 participants
n=5 Participants
|
|
Extent of disease
locally advanced
|
2 participants
n=5 Participants
|
|
Extent of disease
metastatic
|
29 participants
n=5 Participants
|
|
primary tumor site
intrahepatic cholangiocarcinoma
|
25 participants
n=5 Participants
|
|
primary tumor site
gallbladder
|
3 participants
n=5 Participants
|
|
primary tumor site
extrahepatic cholantiocarcinoma
|
3 participants
n=5 Participants
|
|
metastases
lymph nodes
|
24 participants
n=5 Participants
|
|
metastases
lung
|
8 participants
n=5 Participants
|
|
metastases
bone
|
4 participants
n=5 Participants
|
|
metastases
omentum/peritoneal
|
4 participants
n=5 Participants
|
|
metastases
adrenal
|
3 participants
n=5 Participants
|
|
metastases
pelvic soft tissue
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: end of cycle 2 of treatmentTumor measurement - same imaging modality used in pre-treatment evaluation - include radiological examination of all areas with affected disease. For pretreatment and at the end of cycle 2 CT scans (chest/abdomen/pelvis) will be used. For all subsequent cycles, CT of chest/abdomen/pelvis will be used every 8 weeks.
Outcome measures
| Measure |
Panitumumab
n=31 Participants
Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Panitumumab: Day 1 and 15 = 6 mg/kg IV
oxaliplatin: Days 1 and 15 = 85mg/m2 IV
gemcitabine: Days 1 and 15 = 1000 mg/m2 IV
|
|---|---|
|
The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
complete response
|
0 participants
|
|
The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
partial response
|
14 participants
|
|
The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
stable disease
|
14 participants
|
|
The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
progressive disease
|
3 participants
|
SECONDARY outcome
Timeframe: time to cancer progression or deathProgression-free survival was defined as the time from study enrollment to date of cancer progression or death, whichever occurred first. Progression was assessed using CT scans and the Response Evaluation Criteria In Solid Tumors criteria. Progression is defined 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 |
Panitumumab
n=31 Participants
Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Panitumumab: Day 1 and 15 = 6 mg/kg IV
oxaliplatin: Days 1 and 15 = 85mg/m2 IV
gemcitabine: Days 1 and 15 = 1000 mg/m2 IV
|
|---|---|
|
Median Progression Free Survival
|
10.6 months
Interval 4.8 to 24.2
|
SECONDARY outcome
Timeframe: enrollment until date of deathDeath from any cause was used.
Outcome measures
| Measure |
Panitumumab
n=31 Participants
Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Panitumumab: Day 1 and 15 = 6 mg/kg IV
oxaliplatin: Days 1 and 15 = 85mg/m2 IV
gemcitabine: Days 1 and 15 = 1000 mg/m2 IV
|
|---|---|
|
Median Overall Survival
|
20.3 months
Interval 9.1 to 25.1
|
SECONDARY outcome
Timeframe: baseline to study completionAny adverse event continuing after the study completion and considered potentially related to study treatment will be followed until resolution, stabilization or initiation of treatment that confounds the ability to assess the event
Outcome measures
| Measure |
Panitumumab
n=31 Participants
Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Panitumumab: Day 1 and 15 = 6 mg/kg IV
oxaliplatin: Days 1 and 15 = 85mg/m2 IV
gemcitabine: Days 1 and 15 = 1000 mg/m2 IV
|
|---|---|
|
The Number of Participants Who Experience an Adverse Event
|
31 participants
|
Adverse Events
Panitumumab
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Panitumumab
n=31 participants at risk
Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Panitumumab: Day 1 and 15 = 6 mg/kg IV
oxaliplatin: Days 1 and 15 = 85mg/m2 IV
gemcitabine: Days 1 and 15 = 1000 mg/m2 IV
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
83.9%
26/31 • Adverse events were collected for the duration of treatment.
|
|
Blood and lymphatic system disorders
neutropenia
|
22.6%
7/31 • Adverse events were collected for the duration of treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
61.3%
19/31 • Adverse events were collected for the duration of treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
77.4%
24/31 • Adverse events were collected for the duration of treatment.
|
|
General disorders
Fatigue
|
80.6%
25/31 • Adverse events were collected for the duration of treatment.
|
|
Gastrointestinal disorders
Nausea
|
74.2%
23/31 • Adverse events were collected for the duration of treatment.
|
|
Gastrointestinal disorders
abdominal pain
|
29.0%
9/31 • Adverse events were collected for the duration of treatment.
|
|
Gastrointestinal disorders
diarrhea
|
45.2%
14/31 • Adverse events were collected for the duration of treatment.
|
|
Infections and infestations
infection
|
12.9%
4/31 • Adverse events were collected for the duration of treatment.
|
|
Nervous system disorders
neuropathy
|
67.7%
21/31 • Adverse events were collected for the duration of treatment.
|
|
Skin and subcutaneous tissue disorders
rash
|
64.5%
20/31 • Adverse events were collected for the duration of treatment.
|
|
Hepatobiliary disorders
elevated alkaline phosphatase
|
64.5%
20/31 • Adverse events were collected for the duration of treatment.
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
67.7%
21/31 • Adverse events were collected for the duration of treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place