Pancreatic Cancer
Conditions
Brief summary
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.
Detailed description
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer. This research treatment will evaluate the combination of two chemotherapy agents, oxaliplatin and gemcitabine with radiation therapy. The researchers have already done studies using oxaliplatin, gemcitabine and radiation therapy together for pancreatic cancer. They want to build on the information they have from this previous research and do the research at multiple sites. They will use this study to determine how well people do who are treated with gemcitabine, oxaliplatin, and radiation therapy prior to having surgery for their pancreatic cancer. The researchers will also gather more information about what type of side effects occur with this treatment.
Interventions
DRUGgemcitabine
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle.
DRUGoxaliplatin
Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.
PROCEDURERadiation
The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.
Sponsors
Sanofi
Johns Hopkins University
Princess Margaret Hospital, Canada
Ohio State University
University of Michigan Rogel Cancer Center
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
* Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas. * Patients must be deemed resectable or borderline resectable based on criteria in section 4.2 prior to registration. * Patients must have an expected life expectancy of at least 12 weeks and a Zubrod performance status of \< 2. * Patients must have adequate organ function defined as follows: absolute neutrophil count of \> 1500/mm3, platelets \> 100,000/mm3, serum Cr \< 1.5 mg/dl, total bilirubin \< 3.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent). * Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy. * Patients must be aware of the investigational nature of the therapy and provide written informed consent. * Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy. * Patients must not have used any investigational agent in the month before enrollment into the study.
Exclusion criteria
* Patients with neuroendocrine tumors are excluded. * Patients with preexisting peripheral neuropathy \> grade 2 are ineligible. * Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two-year Disease Free Survival. | two years | The percent of patients alive and disease-free at two years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Failure | 2 years | Median time for disease recurrence after surgery. |
| Overall Survival | 5 years | Percent overall survival was calculated for all evaluable patients. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxaliplatin & Gemcitabine With Radiation Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray \[Gy\] fractions (total dose, 30 Gy). | 68 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Non-compliance | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Oxaliplatin & Gemcitabine With Radiation |
|---|---|
| Age, Continuous | 64 years |
| Region of Enrollment Canada | 10 participants |
| Region of Enrollment United States | 58 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 57 / 71 |
| serious Total, serious adverse events | 28 / 71 |
Outcome results
Primary
Two-year Disease Free Survival.
The percent of patients alive and disease-free at two years.
Time frame: two years
Population: 43 patients underwent resection. 41 of the 43 had R0/R1 (surgical margin status) resection. Patients with R02 surgical margins (portions of the tumor visible to the naked eye were not removed) were not included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxaliplatin & Gemcitabine With Radiation | Two-year Disease Free Survival. | 26.1 percentage of patients |
Secondary
Overall Survival
Percent overall survival was calculated for all evaluable patients.
Time frame: 5 years
Population: Of the 71 eligible patients, 68 were evaluable for overall response (1 patient was removed from study during cycle 1 for noncompliance, and 2 additional patients withdrew for reasons not related to toxicity or progression).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oxaliplatin & Gemcitabine With Radiation | Overall Survival | 18.2 months |
Secondary
Time to Treatment Failure
Median time for disease recurrence after surgery.
Time frame: 2 years
Population: 43 patients underwent resection. 41 of the 43 had R0/R1 (surgical margin status) resection. Patients with R02 surgical margins (portions of the tumor visible to the naked eye were not removed) were not included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oxaliplatin & Gemcitabine With Radiation | Time to Treatment Failure | 10.4 months |