Gemcitabine or Combination Chemotherapy Followed by Chemoradiation for Stage IB, II, or III Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— PACT-7  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960284
• Other study ID #: CDR0000641309
• Secondary ID: PACT-7
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 14, 2009
• Last updated: January 12, 2012
• Start date: June 2003
• Est. completion date: June 2009

Study information

• Verified date: January 2012
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• capecitabine
Given orally
• cisplatin
Given IV
• epirubicin hydrochloride
Given IV
• fluorouracil
Given IV
• gemcitabine hydrochloride
Given IV

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, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year progression-free survival (Phase II)		every 3 months during the first 2 years, every 6 months afterwards	No
Secondary	Pattern of relapse		every 3 months during the first 2 years, every 6 months afterwards	No