Gemcitabine or Combination Chemotherapy Followed by Chemoradiation for Stage IB, II, or III Pancreatic Cancer (PACT-7)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michele Reni, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT00960284
First received: August 14, 2009
Last updated: January 12, 2012
Last verified: January 2012

August 14, 2009
January 12, 2012
June 2003
June 2009   (final data collection date for primary outcome measure)
1-year progression-free survival (Phase II) [ Time Frame: every 3 months during the first 2 years, every 6 months afterwards ] [ Designated as safety issue: No ]
  • 1-year progression-free survival (Phase II) [ Designated as safety issue: No ]
  • 2-year overall survival (Phase III) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00960284 on ClinicalTrials.gov Archive Site
Pattern of relapse [ Time Frame: every 3 months during the first 2 years, every 6 months afterwards ] [ Designated as safety issue: No ]
  • Feasibility and toxicity [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
  • Pattern of relapse [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Gemcitabine or Combination Chemotherapy Followed by Chemoradiation for Stage IB, II, or III Pancreatic Cancer
Randomized Phase II-III Trial of Post-operative Treatment of Pancreatic Adenocarcinoma: Gemcitabine Versus PEFG Followed by Radiochemotherapy With Concomitant Continuous Infusion of 5-fluorouracil

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, epirubicin hydrochloride, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether gemcitabine hydrochloride is more effective when given alone or together with combination chemotherapy and radiation therapy in treating patients with pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying gemcitabine hydrochloride to see how well it works when given alone or together with combination chemotherapy and radiation therapy in treating patients with stage IB, stage II, or stage III pancreatic cancer.

OBJECTIVES:

Primary

  • Assess the 1-year progression-free survival of patients with stage IB, II, or III adenocarcinoma of the pancreas treated with adjuvant therapy comprising gemcitabine with vs without cisplatin, epirubicin hydrochloride, and fluorouracil followed by chemoradiotherapy with fluorouracil or capecitabine. (Phase II)
  • Compare the 2-year overall survival of patients treated with these regimens. (Phase III)

Secondary

  • Assess the feasibility and toxicity of these regimens in these patients.
  • Assess the impact of these regimens on the quality of life of these patients.
  • Assess the pattern of relapse in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center and radical surgery. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine hydrochloride IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive cisplatin IV over 1 hour and epirubicin hydrochloride IV on day 1 and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Patients also receive fluorouracil IV continuously beginning on day 1 or oral capecitabine. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Beginning 2-4 weeks after the completion of chemotherapy, patients in both arms undergo radiotherapy 5 days a week for 6 weeks. Patients also receive concurrent fluorouracil IV continuously or oral capecitabine during radiotherapy.

After completion of study treatment, patients are followed up every 3 months.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: capecitabine
    Given orally
    Other Name: XELODA
  • Drug: cisplatin
    Given IV
    Other Name: Cisplatino-TEVA
  • Drug: epirubicin hydrochloride
    Given IV
    Other Name: Farmarubicina
  • Drug: fluorouracil
    Given IV
    Other Name: FLuorouracile-TEVA
  • Drug: gemcitabine hydrochloride
    Given IV
    Other Name: Gemzar
  • Experimental: Arm I
    Patients receive gemcitabine hydrochloride IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
    Intervention: Drug: gemcitabine hydrochloride
  • Experimental: Arm II
    Patients receive cisplatin IV over 1 hour and epirubicin hydrochloride IV on day 1 and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Patients also receive fluorouracil IV continuously beginning on day 1 or oral capecitabine. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: capecitabine
    • Drug: cisplatin
    • Drug: epirubicin hydrochloride
    • Drug: fluorouracil
    • Drug: gemcitabine hydrochloride
Reni M, Passoni P, Bonetto E, Balzano G, Panucci MG, Zerbi A, Ronzoni M, Staudacher C, Villa E, Di Carlo V. Final results of a prospective trial of a PEFG (Cisplatin, Epirubicin, 5-Fluorouracil, Gemcitabine) regimen followed by radiotherapy after curative surgery for pancreatic adenocarcinoma. Oncology. 2005;68(2-3):239-45. Epub 2005 Jul 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
June 2009
June 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the pancreas

    • Stage IB-III disease
  • Has undergone surgery with radical intent (R0 or R1) within the past 2 months

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100% (90-100% for patients 71-75 years of age)
  • WBC ≥ 3,500/mm^3
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 2 mg/dL
  • SGOT and SGPT ≤ 2 times upper limit of normal
  • Not pregnant or nursing
  • No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
  • No psychological, familial, sociological, or geographical condition that would potentially hinder study compliance or follow-up schedule

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy or radiotherapy for pancreatic adenocarcinoma
  • No other concurrent experimental drugs
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00960284
CDR0000641309, PACT-7
No
Michele Reni, IRCCS San Raffaele
IRCCS San Raffaele
Not Provided
Principal Investigator: Michele Reni, MD Istituto Scientifico H. San Raffaele
IRCCS San Raffaele
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP