Biliary Tract Cancer
Conditions
Brief summary
To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer
Interventions
DRUGgemcitabine
1000 milligrams per square meter (mg/m2), intravenous (IV)
DRUGcisplatin
25 milligrams per square meter (mg/m2), intravenous (IV)
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological or cytological diagnosis of biliary tract cancer * Measurable disease must be at least one lesion * Chemotherapy-naïve * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Estimated life expectancy no less than 3 months
Exclusion criteria
* radiological or clinical evidence of pulmonary fibrosis or interstitial pneumonia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Alive at 1 Year (1-Year Survival Rate) | 1 year | Percentage of patients alive at 1 year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response | baseline to measured progressive disease (up to 2 years) | Response Evaluation Criteria In Solid Tumors - define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Complete response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria. |
| Progression Free Survival | baseline to measured progressive disease (up to 2 years) | The period from study entry until disease progression, death or date of last contact. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Survival Time | baseline to date of death due to any cause (up to 2 years) | Data of patients lost to follow-up were censored at the last date of confirmation of their survival. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine + Cisplatin Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. | 41 |
| Gemcitabine Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. | 42 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 3 |
| Overall Study | Next Cycle Not Started | 4 | 0 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Unequivocal Disease Progression | 25 | 34 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Gemcitabine + Cisplatin | Gemcitabine | Total |
|---|---|---|---|
| Age Continuous | 63.7 years STANDARD_DEVIATION 10.1 | 67.0 years STANDARD_DEVIATION 6.9 | 65.4 years STANDARD_DEVIATION 8.7 |
| Body Surface Area | 1.555 square meter (m^2) STANDARD_DEVIATION 0.195 | 1.523 square meter (m^2) STANDARD_DEVIATION 0.158 | 1.539 square meter (m^2) STANDARD_DEVIATION 0.177 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - Fully Active | 34 participants | 28 participants | 62 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 - Ambulatory, Restricted Strenuous Activity | 7 participants | 14 participants | 21 participants |
| Height | 159.80 centimeters (cm) STANDARD_DEVIATION 8.75 | 156.67 centimeters (cm) STANDARD_DEVIATION 8.62 | 158.21 centimeters (cm) STANDARD_DEVIATION 8.77 |
| Primary Tumor Extrahepatic Bile Duct | 8 participants | 11 participants | 19 participants |
| Primary Tumor Gallbladder | 15 participants | 17 participants | 32 participants |
| Primary Tumor Intrahepatic Bile Duct | 14 participants | 14 participants | 28 participants |
| Primary Tumor Papilla | 4 participants | 0 participants | 4 participants |
| Region of Enrollment Japan | 41 participants | 42 participants | 83 participants |
| Sex: Female, Male Female | 23 Participants | 21 Participants | 44 Participants |
| Sex: Female, Male Male | 18 Participants | 21 Participants | 39 Participants |
| Tumor Histological Type Adenocarcinoma | 39 participants | 41 participants | 80 participants |
| Tumor Histological Type Adenosquamous Cancer | 2 participants | 1 participants | 3 participants |
| Weight | 54.97 kilograms (kg) STANDARD_DEVIATION 12.31 | 53.91 kilograms (kg) STANDARD_DEVIATION 9.5 | 54.43 kilograms (kg) STANDARD_DEVIATION 10.92 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 41 / 41 | 42 / 42 |
| serious Total, serious adverse events | 9 / 41 | 17 / 42 |
Outcome results
Primary
Percentage of Patients Alive at 1 Year (1-Year Survival Rate)
Percentage of patients alive at 1 year.
Time frame: 1 year
Population: Number of patients who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gemcitabine + Cisplatin | Percentage of Patients Alive at 1 Year (1-Year Survival Rate) | 39 percentage of participants |
| Gemcitabine | Percentage of Patients Alive at 1 Year (1-Year Survival Rate) | 31 percentage of participants |
Secondary
Progression Free Survival
The period from study entry until disease progression, death or date of last contact.
Time frame: baseline to measured progressive disease (up to 2 years)
Population: Number of patients who received at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine + Cisplatin | Progression Free Survival | 5.8 months |
| Gemcitabine | Progression Free Survival | 3.7 months |
p-value: 0.074Log Rank
Secondary
Tumor Response
Response Evaluation Criteria In Solid Tumors - define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Complete response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria.
Time frame: baseline to measured progressive disease (up to 2 years)
Population: Number of patients who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine + Cisplatin | Tumor Response | Partial Response | 8 participants |
| Gemcitabine + Cisplatin | Tumor Response | Progressive Disease | 9 participants |
| Gemcitabine + Cisplatin | Tumor Response | Stable Disease | 20 participants |
| Gemcitabine + Cisplatin | Tumor Response | Not Evaluable | 4 participants |
| Gemcitabine + Cisplatin | Tumor Response | Complete Response | 0 participants |
| Gemcitabine | Tumor Response | Not Evaluable | 4 participants |
| Gemcitabine | Tumor Response | Complete Response | 0 participants |
| Gemcitabine | Tumor Response | Partial Response | 5 participants |
| Gemcitabine | Tumor Response | Stable Disease | 16 participants |
| Gemcitabine | Tumor Response | Progressive Disease | 17 participants |
p-value: 0.38Fisher Exact
Other Pre-specified
Survival Time
Data of patients lost to follow-up were censored at the last date of confirmation of their survival.
Time frame: baseline to date of death due to any cause (up to 2 years)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine + Cisplatin | Survival Time | 11.2 months |
| Gemcitabine | Survival Time | 7.7 months |
p-value: 0.136Log Rank