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Gemcitabine, Cisplatin, Epirubicin, and Capecitabine in Treating Patients With Stage I-II Resectable Pancreatic Cancer (PACT-15)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01150630
First Posted: June 25, 2010
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michele Reni, IRCCS San Raffaele
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer Drug: capecitabine Drug: cisplatin Drug: epirubicin Drug: gemcitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II-III Trial of Peri- or Post-Operative Chemotherapy in Resectable Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Michele Reni, IRCCS San Raffaele:

Primary Outcome Measures:
  • Event-free survival at 1 year (phase II) [ Time Frame: every 3 months ]
    CT scan


Secondary Outcome Measures:
  • Radiological, biochemical, and pathological response rate (neoadjuvant arm only) [ Time Frame: after 3 months of induction therapy ]
    CT scan, CA19.9 serology; pathology report

  • Surgical resection rate [ Time Frame: immediately after surgery ]
    surgeon report

  • Surgical mortality and morbidity [ Time Frame: immediately after surgery ]
    surgeon report

  • Tolerability [ Time Frame: every 2 weeks during therapy ]
    outpatient visit; laboratory report

  • Proportion of patients with negative surgical margins [ Time Frame: immediately after surgery ]
    pathology report

  • Lymph node status [ Time Frame: immediately after surgery ]
    pathology report


Enrollment: 98
Study Start Date: May 2010
Study Completion Date: August 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: adjuvant PEXG
cisplatin and epirubicin at 30 mg/mq, gemcitabine at 800 mg/mq and capecitabine at 1250 mg/mq/day per os for 14 days every 14 days for 6 months
Drug: capecitabine
1250 mg/mq/day per os for 14 days every 14 days for 6 months
Other Name: XELODA
Drug: cisplatin
30 mg/mq every 14 days for 6 months
Other Name: cisplatino TEVA
Drug: epirubicin
30 mg/mq every 14 days for 6 months
Other Name: farmorubicina
Drug: 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
Other Name: GEMZAR
Experimental: perioperative PEXG
cisplatin and epirubicin at 30 mg/mq, gemcitabine at 800 mg/mq and capecitabine at 1250 mg/mq/day per os for 14 days every 14 days for 3 months before surgery and 3 months after surgery
Drug: capecitabine
1250 mg/mq/day per os for 14 days every 14 days for 6 months
Other Name: XELODA
Drug: cisplatin
30 mg/mq every 14 days for 6 months
Other Name: cisplatino TEVA
Drug: epirubicin
30 mg/mq every 14 days for 6 months
Other Name: farmorubicina
Drug: 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
Other Name: GEMZAR
Active Comparator: Adjuvant Gemcitabine
Adjuvant Gemcitabine at 1000 mg/mq for 3 weeks every 4 weeks for 6 months
Drug: 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
Other Name: GEMZAR

Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150630


Locations
Italy
Istituto Scientifico H. San Raffaele
Milan, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Michele Reni, MD Istituto Scientifico H. San Raffaele
  More Information

Responsible Party: Michele Reni, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01150630     History of Changes
Other Study ID Numbers: CDR0000675485
PACT-15 ( Other Identifier: IRCCS San Raffaele )
2010-019942-23 ( EudraCT Number )
First Submitted: June 24, 2010
First Posted: June 25, 2010
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michele Reni, IRCCS San Raffaele:
adenocarcinoma of the pancreas
stage I pancreatic cancer
stage II pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Cisplatin
Capecitabine
Epirubicin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors