Biliary Cancer, Cholangiocarcinoma
Conditions
Keywords
Biliary Cancer, Cholangiocarcinoma, Panitumumab
Brief summary
This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.
Interventions
DRUGGemcitabine, Irinotecan, Panitumumab
Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologically or cytologically confirmed local advanced unresectable/metastatic adenocarcinoma of biliary tract * measurable disease * available tumor tissue for investigational immunohistochemical evaluations * ECOG PS 0-2 * No prior chemotherapy, biologic therapy or radiation therapy * Age Eighteen and older * Lab values per protocol
Exclusion criteria
* Life expectancy less than three months * Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs less than four weeks prior to enrollment * Prior therapy, which affects or targets the EGF pathway * Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer * Recovery from major surgery within three weeks of the start of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival Rate at Five Months | 5 months |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate From Combination Chemotherapy | 5 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chemotherapy Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Chemotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 62 years |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 35 |
| serious Total, serious adverse events | 21 / 35 |
Outcome results
Primary
Progression Free Survival Rate at Five Months
Time frame: 5 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemotherapy | Progression Free Survival Rate at Five Months | 69 percentage of participants |
Secondary
Response Rate From Combination Chemotherapy
Time frame: 5 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemotherapy | Response Rate From Combination Chemotherapy | Complete Response | 2 Participants |
| Chemotherapy | Response Rate From Combination Chemotherapy | Partial Response | 9 Participants |
| Chemotherapy | Response Rate From Combination Chemotherapy | Stable Disease | 15 Participants |
| Chemotherapy | Response Rate From Combination Chemotherapy | Progressive Disease | 2 Participants |
| Chemotherapy | Response Rate From Combination Chemotherapy | Not Assessable | 7 Participants |