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

Pancreatic Cancer Clinical Trial

— PACT-15  

Official title:

Randomized Phase II-III Trial of Peri- or Post-Operative Chemotherapy in Resectable Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150630
• Other study ID #: CDR0000675485
• Secondary ID: PACT-152010-0199
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2010
• Last updated: August 31, 2017
• Start date: May 2010
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• To assess the proportion of patients who are event-free (defined as disease progression, local recurrence, distant metastasis, new tumor, or death) at 1 year after neoadjuvant therapy comprising gemcitabine hydrochloride with cisplatin, epirubicin hydrochloride, and capecitabine (PEXG), and adjuvant chemotherapy comprising gemcitabine hydrochloride or PEXG regimen in patients with resectable stage I or II adenocarcinoma of the pancreas. (phase II)

• To assess whether the best experimental regimen, which will be selected on the basis of the phase II part of the trial, is able to improve overall survival when compared to standard adjuvant gemcitabine in these patients. (phase III)

Secondary

• To assess radiological, biochemical, and pathological response rate (neoadjuvant arm only) in these patients.

• To assess surgical resection rate, surgical mortality and morbidity, and proportion of patients with negative surgical margins.

• To assess lymph node status in these patients.

• To determine tolerability of these regimens in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to center. Patients are randomized to 1 of 3 treatment arms.

• Arm I (adjuvant gemcitabine hydrochloride) : Patients receive gemcitabine hydrochloride IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.

• Arm II (adjuvant cisplatin, epirubicin hydrochloride, gemcitabine hydrochloride, and capecitabine [PEXG regimen]): Patients receive cisplatin IV over 1 hour on days 1-5, epirubicin hydrochloride IV on days 1 and 8, gemcitabine hydrochloride IV over 1 hour on days 1 and 8, and oral capecitabine on days 1-14. Treatment repeats every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.

• Arm III (neoadjuvant and adjuvant PEXG regimen): Patients receive neoadjuvant cisplatin IV over 1 hour on days 1-5, epirubicin hydrochloride IV on days 1 and 8, gemcitabine hydrochloride IV over 1 hour on days 1 and 8, and oral capecitabine on days 1-14. Treatment repeats every 14 days for up to 3 months. Patients then undergo surgery for pancreatic cancer followed by adjuvant (within 2 months of surgery) PEXG given as in neoadjuvant therapy. Treatment with adjuvant PEXG repeats every 14 days for 3 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, and then every 6 months thereafter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: August 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• capecitabine
1250 mg/mq/day per os for 14 days every 14 days for 6 months
• cisplatin
30 mg/mq every 14 days for 6 months
• epirubicin
30 mg/mq every 14 days for 6 months
• gemcitabine
ARM A: 1000 mg/mq for 3 weekly infusions every 4 weeks for 6 months ARM B and C: 800 mg/mq every 14 days for 6 months

Locations

Country	Name	City	State
Italy	Istituto Scientifico H. San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival at 1 year (phase II)	CT scan	every 3 months
Secondary	Radiological, biochemical, and pathological response rate (neoadjuvant arm only)	CT scan, CA19.9 serology; pathology report	after 3 months of induction therapy
Secondary	Surgical resection rate	surgeon report	immediately after surgery
Secondary	Surgical mortality and morbidity	surgeon report	immediately after surgery
Secondary	Tolerability	outpatient visit; laboratory report	every 2 weeks during therapy
Secondary	Proportion of patients with negative surgical margins	pathology report	immediately after surgery
Secondary	Lymph node status	pathology report	immediately after surgery