A Phase 2 interventional study of Gemcitabine and nanoparticle albumin bound paclitaxel and 5-fluorouracil and irinotecan in Ductal Adenocarcinoma of Pancreas and Adenocarcinoma of Ampulla, sponsored by Essentia Health. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-11-13.
Sponsored by Essentia Health · Phase 2, Interventional, and Treatment
Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.
Patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior therapy and have no clinically detectable metastatic disease will be enrolled. Management will be driven by resectability status as defined by the American College of Surgeons. All patients will be defined at entry as Resectable, Borderline Resectable or Locally Advanced (Unresectable).
All patients will be treated initially with gemcitabine and nanoparticle albumin bound paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. Patients classified as Resectable, who have CA19-9 below 180 and CA-125 below 30 will then proceed to resection. All other patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan (FOLFIRI-3) every 14 days x 4 cycles.
All patients without progression will then receive chemoradiation consisting of external beam radiotherapy (40 Gy in 20 fractions given over 4 weeks). During radiation all patients will receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week, Mitomycin-C at 3 mg.m2 on d1, 8, 15 \& 22; Cisplatin at 10 mg/m2 on d2, 9, 16, 23 and unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28.
After approximately 4 weeks to recover from chemoradiation, all patients with Resectable or Borderline Resectable disease will undergo definitive surgery.
Adjuvant therapy with FOLFIR-3 for an additional 6 cycles will be offered to all patients post-operatively.
Patients will then be actively followed every 3 to 6 months in keeping with National Comprehensive Cancer Network (NCCN) guidelines for 2 yrs, and then followed for recurrence, late toxicity and vital status every 6 months through 5 years.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 11 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Essentia Health is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.
Drug: Gemcitabine and nanoparticle albumin bound paclitaxel · Procedure: Definitive resection
Systemic chemotherapy followed by chemoradiation, followed by definitive surgery
Drug: Gemcitabine and nanoparticle albumin bound paclitaxel · Drug: 5-fluorouracil and irinotecan · Radiation: Preoperative chemoradiation · Procedure: Definitive resection
Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles
Also known as: Gem/Abraxane, Gemcitabine/nab-paclitaxel
FOLFIRI.3 given every 14 days x 4 cycles
Also known as: FOLFIRI.3, FOLFIRI-3
Pre-operative chemoradiation to 40 Gy in 20 fractions
Definitive surgical resection of primary tumor
Also known as: pancreaticoduodenectomy, Whipple procedure
Relapse Free Survival
Percentage of patients alive and free of detectable disease 1 yr from start of treatment
Time frame: 1 yr form onset of treatment
R-0 Rate
Rate of patients having surgery who have negative surgical margins (i.e. R-0 resection)
Time frame: Time of surgery
Overall Survival
Time to death from any cause measured from start of treatment
Time frame: Up to 3 years from registration
| Milestone | Resectable, Low Risk | Locally Advanced |
|---|---|---|
| Started | 1 | 10 |
| Completed | 0 | 0 |
| Not completed | 1 | 10 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Adverse event | 0 | 4 |
| Withdrew: Lack of efficacy | 0 | 2 |
| Withdrew: Did not start protocol therapy | 0 | 2 |
| Withdrew: Study terminated | 0 | 1 |
Percentage of patients alive and free of detectable disease 1 yr from start of treatment
No measurements were reported for this outcome.
Rate of patients having surgery who have negative surgical margins (i.e. R-0 resection)
No measurements were reported for this outcome.
Time to death from any cause measured from start of treatment
No measurements were reported for this outcome.
Collected over Study enrollment through study termination, on average approximately 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Resectable, Low Risk | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Locally Advanced | 1/10 (10%) | 3/10 (30%) | 2/10 (20%) |
| Event | Resectable, Low Risk | Locally Advanced |
|---|---|---|
| diarrheaGastrointestinal disorders | 0/1 | 3/10 |
| NeutropeniaBlood and lymphatic system disorders | 0/1 | 1/10 |
| Event | Resectable, Low Risk | Locally Advanced |
|---|---|---|
| NauseaGastrointestinal disorders | 0/1 | 2/10 |
| diarrheaGastrointestinal disorders | 0/1 | 2/10 |
| Age, Categorical(Participants) | Resectable, Low Risk | Locally Advanced | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 7 | 8 |
| >=65 years | 0 | 3 | 3 |
| Age, Continuous(years) | Resectable, Low Risk | Locally Advanced | Total |
|---|---|---|---|
| Median | 64 (64 to 64) | 63 (57 to 80) | 63 (57 to 80) |
| Sex: Female, Male(Participants) | Resectable, Low Risk | Locally Advanced | Total |
|---|---|---|---|
| Female | 1 | 6 | 7 |
| Male | 0 | 4 | 4 |
| Race and Ethnicity Not Collected(Participants) | Resectable, Low Risk | Locally Advanced | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Resectable, Low Risk | Locally Advanced | Total |
|---|---|---|---|
| United States | 1 | 10 | 11 |
Plan to share: Yes — We will make unidentified dataset available for electronic download.
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This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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