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

Sponsor

IRCCS San Raffaele (Other)

Overall Status

Completed

CT.gov ID

NCT00960284

Collaborator

(none)

102

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: capecitabine Drug: cisplatin Drug: epirubicin hydrochloride Drug: fluorouracil Drug: gemcitabine hydrochloride	Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: gemcitabine hydrochloride Given IV Other Names: Gemzar
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.	Drug: capecitabine Given orally Other Names: XELODA Drug: cisplatin Given IV Other Names: Cisplatino-TEVA Drug: epirubicin hydrochloride Given IV Other Names: Farmarubicina Drug: fluorouracil Given IV Other Names: FLuorouracile-TEVA Drug: gemcitabine hydrochloride Given IV Other Names: Gemzar

Arm

Intervention/Treatment

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.

Drug: gemcitabine hydrochloride

Given IV

Other Names:

Gemzar

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.

Drug: capecitabine

Given orally

Other Names:

XELODA

Drug: cisplatin

Given IV

Other Names:

Cisplatino-TEVA

Drug: epirubicin hydrochloride

Given IV

Other Names:

Farmarubicina

Drug: fluorouracil

Given IV

Other Names:

FLuorouracile-TEVA

Drug: gemcitabine hydrochloride

Given IV

Other Names:

Gemzar

Outcome Measures

Primary Outcome Measures

1-year progression-free survival (Phase II) [every 3 months during the first 2 years, every 6 months afterwards]

Secondary Outcome Measures

Pattern of relapse [every 3 months during the first 2 years, every 6 months afterwards]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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