Clinical trial NCT00262951
Conditions: Pancreatic Cancer
Keywords: stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2005-01-01; Completion date: 2011-08-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Interferon alfa may interfere with the growth of tumor cells. Giving combination chemotherapy and radiation therapy together with interferon alfa before surgery may shrink the tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy and radiation therapy together with interferon alfa works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* Determine the effect of neoadjuvant chemoradiotherapy and interferon alfa on converting patients with locally advanced unresectable adenocarcinoma of the pancreas to resectability.

Secondary

* Determine the rate and severity of early and late toxic effects of these regimens in these patients.
* Improve surgical morbidity profile and overall survival of patients who undergo surgical resection.
* Determine overall and progression-free survival of patients treated with this regimen.

OUTLINE: This is an pilot, single center study.

* Part 1 (neoadjuvant therapy): Patients receive fluorouracil IV continuously over 24 hours on days 1-38; cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36; and interferon alfa subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, and 38. Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients then undergo restaging. Patients with resectable disease undergo surgery, and 4-10 weeks later, proceed to part 2. Patients with unresectable disease proceed directly to part 2, 4 weeks after completion of neoadjuvant therapy.
* Part 2 (chemotherapy): Patients receive fluorouracil IV on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with unresectable disease undergo restaging after each course of fluorouracil. If the tumor subsequently becomes resectable, patients then undergo surgery.

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

Arms: arm 1: Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery).
Interventions: intervention 1: recombinant interferon alfa intervention 2: cisplatin intervention 3: fluorouracil intervention 4: radiation therapy intervention 5: Resection of tumor
Intervention descriptions: intervention 1: administered subcutaneously (SQ)at a dose of 3 million units Day 1,3, and 5 each week in Cycle 1 intervention 2: administered at a dose of 30 mg/m2 intravenously (IV) day 1 each week in Cycle 1 intervention 3: administered at a dose of 175 mg/m\^2/day continuous infusion (CI) for 38 days in Cycle 1 and then 500 mg/m\^2 intravenously (IV) each week for 6 weeks followed by a 2 week rest (1 cycle = 8 weeks)in Cycle 2 and 3 intervention 4: 5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks (days 1-5, 8-12, 15-19, 22-26, 29-33, 36-38). intervention 5: After Cycle 1 treatment (if resectable)- In the absence of metastatic disease, special emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. Surgical exploration will start with a diagnostic laparoscopy. If no evidence of carcinomatosis, liver metastases or other evidence of metastatic disease is encountered, then a laparotomy will be performed. In the absence of clear technical unresectability, a radical pancreaticoduodenectomy, distal or total pancreatectomy (and resection of any involved structures) will be performed as mandated by tumor anatomy.

Protocol documents: