Gemcitabine, Cisplatin, Epirubicin, and Capecitabine in Treating Patients With Stage I-II Resectable Pancreatic Cancer

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, epirubicin hydrochloride, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine hydrochloride, with or without cisplatin, epirubicin hydrochloride, and capecitabine before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This randomized phase II/III trial is studying how well gemcitabine hydrochloride, with or without cisplatin, epirubicin hydrochloride, and capecitabine, works when given before and/or after surgery in treating patients with stage I or stage II pancreatic cancer that can be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele
• Treatments: Capecitabine; Cisplatin; Epirubicin; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically* confirmed adenocarcinoma of pancreas

• Stage I-II disease

• Resectable disease

• No superior mesenteric vein or artery, portal vein, celiac trunk, or hepatic artery infiltration

• No symptomatic duodenal stenosis

• NOTE: Patients without histological or cytological results may be allowed provided ≥ 1 attempt has been made by needle aspiration with negative imaging and clinical signs suggestive of adenocarcinoma.

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• WBC ≥ 3,500/mm³

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 10 g/dL

• Creatinine ≤ 1.5 mg/dL

• ALT and AST ≤ 3 times upper limit of normal

• Bilirubin ≤ 3 mg/dL

• No prior or concurrent malignancy within the past 5 years except for surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin

• Not pregnant or nursing

• No psychological, familial, sociological, or geographical condition that would potentially hinder study compliance or follow-up schedule

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy for pancreatic adenocarcinoma

• No other concurrent experimental drugs