Ampullary Cancer, Cholangiocarcinoma Cancer, Gallbladder Cancer, Pancreatic Cancer
Conditions
Keywords
Cholangiocarcinoma, Gallbladder, Pancreatic, Ampullary, Cancer
Brief summary
To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.
Interventions
DRUGGemcitabine
DRUGDocetaxel
RADIATIONRadiation
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have biopsy-proven, resected with curative intent cholangiocarcinoma, gallbladder, pancreatic or ampullary adenocarcinoma. * Patients must be 18 years or older. * Patients must have a NCI CTC Performance Status of 0-2. * Patients must not have any prior chemotherapy or radiation therapy for this current malignancy. * At least 3 weeks should have elapsed since any surgery requiring general anesthesia. * Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ, unless in remission for \>5years * Pregnant patients are not eligible. Non-pregnant status will be determined in all women of childbearing potential. All patients will be required to use an effective means of contraception if sexually active during therapy. * Initial Required Laboratory Values: * Absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 150, 000/mm3, and hemoglobin ≥ 9 g/dL. * Serum creatinine should be ≤ 2 mg/dL. * Serum bilirubin should be ≤ 3.0 mg/dL (biliary stents allowed). * Serum transaminases should be ≤ 5-fold the institutional upper limits. * Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection. * Patients must be able to sign an informed consent.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Severe Toxicities | 1 month after completion of treatment (treatment lasts approximately 19 weeks) | Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicities Associated With Treatment (Grade 1-2) | 30 days after completion of treatment (treatment lasts approximately 19 weeks) | Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome. |
| Toxicities Associated With Treatment (Grade 3-4) | 30 days after completion of treatment (treatment lasts approximately 19 weeks) | Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome. |
| Disease Free Survival (DFS) - Median | Median follow-up was 24 months (range 3.2-97 months) | DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first. |
| Overall Survival (OS) - Median | Median follow-up was 24 months (range 3.2-97 months) | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up. |
| Overall Survival (OS) | 1 year | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up |
Countries
United States
Participant flow
Recruitment details
The study opened to participants enrollment on 09/14/2002 and closed to participant enrollment on 11/06/2012
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation) Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation) |
|---|---|
| Age, Continuous | 59 years |
| CA 19-9 (tumor marker) >100 | 5 participants |
| CA 19-9 (tumor marker) <40 | 34 participants |
| CA 19-9 (tumor marker) 40-100 | 11 participants |
| Differentiation Moderate | 17 participants |
| Differentiation Not reported | 1 participants |
| Differentiation Poor | 28 participants |
| Differentiation Well | 4 participants |
| Disease type Ampullary cancer | 9 participants |
| Disease type Biliary tract cancer | 12 participants |
| Disease type Pancreatic cancer | 29 participants |
| Lymphovascular involvement No | 9 participants |
| Lymphovascular involvement Not Reported | 5 participants |
| Lymphovascular involvement Yes | 36 participants |
| N-stage 0 | 10 participants |
| N-stage 1 | 36 participants |
| N-stage X | 4 participants |
| Overall stage I | 3 participants |
| Overall stage II | 46 participants |
| Overall stage III | 1 participants |
| Overall stage IV | 0 participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 21 Participants |
| T-stage 1 | 2 participants |
| T-stage 2 | 11 participants |
| T-stage 3 | 35 participants |
| T-stage 4 | 2 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 48 / 48 |
| serious Total, serious adverse events | 16 / 48 |
Outcome results
Primary
Incidence of Severe Toxicities
Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0
Time frame: 1 month after completion of treatment (treatment lasts approximately 19 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 | Incidence of Severe Toxicities | 20 percentage of participants |
Secondary
Disease Free Survival (DFS) - Median
DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.
Time frame: Median follow-up was 24 months (range 3.2-97 months)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm 1 | Disease Free Survival (DFS) - Median | Pancreatic cancer | 9.6 months |
| Arm 1 | Disease Free Survival (DFS) - Median | Biliary/ampullary cancer | 12.7 months |
Secondary
Disease Free Survival (DFS) - Median
DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.
Time frame: Median follow-up was 24 months (range 3.2-97 months)
Population: 30 out of 48 participants completed all components of the study therapy.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm 1 | Disease Free Survival (DFS) - Median | Pancreatic cancer | 12.8 months |
| Arm 1 | Disease Free Survival (DFS) - Median | Biliary cancer/ampullary cancer | 15.0 months |
Secondary
Overall Survival (OS)
OS was defined as the time from the initiation of treatment to death from any cause or last follow-up
Time frame: 1 year
Population: 30 out of 48 participants completed all components of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 | Overall Survival (OS) | Pancreatic cancer | 78.6 percentage of participants |
| Arm 1 | Overall Survival (OS) | Biliary/ampullary cancer | 81.2 percentage of participants |
Secondary
Overall Survival (OS)
OS was defined as the time from the initiation of treatment to death from any cause or last follow-up
Time frame: 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 | Overall Survival (OS) | Pancreatic cancer | 60.7 percentage of participants |
| Arm 1 | Overall Survival (OS) | Biliary/ampullary cancer | 75.0 percentage of participants |
Secondary
Overall Survival (OS)
OS was defined as the time from the initiation of treatment to death from any cause or last follow-up
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 | Overall Survival (OS) | Pancreatic cancer | 32.1 percentage of participants |
| Arm 1 | Overall Survival (OS) | Biliary/ampullary cancer | 49.1 percentage of participants |
Secondary
Overall Survival (OS) - Median
OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.
Time frame: Median follow-up was 24 months (range 3.2-97 months)
Population: 30 out of 48 participants completed all components of study treatment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm 1 | Overall Survival (OS) - Median | Pancreatic cancer | 24.5 months |
| Arm 1 | Overall Survival (OS) - Median | Biliary cancer/ampullary cancer | 23.8 months |
Secondary
Overall Survival (OS) - Median
OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.
Time frame: Median follow-up was 24 months (range 3.2-97 months)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm 1 | Overall Survival (OS) - Median | Pancreatic cancer | 17.6 months |
| Arm 1 | Overall Survival (OS) - Median | Biliary cancer/ampullary cancer | 23.8 months |
Secondary
Toxicities Associated With Treatment (Grade 1-2)
Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome.
Time frame: 30 days after completion of treatment (treatment lasts approximately 19 weeks)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 | Toxicities Associated With Treatment (Grade 1-2) | Mucositis | 31 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 1-2) | Nausea | 48 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 1-2) | Vomiting | 23 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 1-2) | Diarrhea | 31 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 1-2) | Dehydration | 17 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 1-2) | Weight loss | 27 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 1-2) | Fatigue | 67 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 1-2) | Renal toxicity | 13 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 1-2) | Hepatotoxicity | 69 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 1-2) | Infection | 13 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 1-2) | Neutropenia | 46 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 1-2) | Anemia | 65 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 1-2) | Thrombocytopenia | 46 percentage of participants |
Secondary
Toxicities Associated With Treatment (Grade 3-4)
Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome.
Time frame: 30 days after completion of treatment (treatment lasts approximately 19 weeks)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 | Toxicities Associated With Treatment (Grade 3-4) | Mucositis | 2 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 3-4) | Nausea | 4 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 3-4) | Vomiting | 4 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 3-4) | Diarrhea | 15 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 3-4) | Dehydration | 4 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 3-4) | Weight loss | 0 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 3-4) | Fatigue | 8 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 3-4) | Renal toxicity | 0 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 3-4) | Hepatotoxicity | 4 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 3-4) | Infection | 15 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 3-4) | Neutropenia | 23 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 3-4) | Anemia | 4 percentage of participants |
| Arm 1 | Toxicities Associated With Treatment (Grade 3-4) | Thrombocytopenia | 6 percentage of participants |
Post Hoc
Incidence of Disease Recurrence
Time frame: Median follow-up was 24 months (range 3.2-97 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 | Incidence of Disease Recurrence | 83 percentage of participants |