Second Line Chemotherapy for Advanced Pancreatic Cancer

NCT ID: NCT01543412

Last Updated: 2012-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-12-31

Brief Summary

No validated second-line chemotherapy for the treatment of locally advanced/metastatic pancreatic cancer is actually available,after the failure of a gemcitabine(+/- Cisplatin or Oxaliplatin)-based regimen.

Irinotecan seems to be a moderately active drug in the treatment of this disease Recently was reported some interesting results using a potentially non -cross resistant regimen (FOLFIRI) which could be useful even as second-line chemotherapy.

An exploratory study in this setting seem warranted.

Conditions

Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FOLFIRI

Folfiri consist of Irinotecan 180 mg/m2 iv on day 1, Leucovorin(l-form) 200 mg/m2 iv on day 1and 2, 5-FU 400 mg/m2 iv bolus on day 1and 2, 5-FU 600 mg/m2 iv by ci for 22 hours on day 1 and 2, repeated every 2 wks The use of antiemetic prophylaxis was decided locally.

Group Type: EXPERIMENTAL

FOLFIRI

Intervention Type: DRUG

Irinotecan 180 mg/m2 iv on day 1, Leucovorin(l-form) 200 mg/m2 iv on day 1,2 5-FU 400 mg/m2 iv bolus on day 1,2 5-FU 600 mg/m2 iv by ci for 22 hrs on day 1,2 repeated every 2 wks

Interventions

FOLFIRI

Irinotecan 180 mg/m2 iv on day 1, Leucovorin(l-form) 200 mg/m2 iv on day 1,2 5-FU 400 mg/m2 iv bolus on day 1,2 5-FU 600 mg/m2 iv by ci for 22 hrs on day 1,2 repeated every 2 wks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed written informed consent prior to beginning protocol specific procedures
• Previous chemotherapy with Gemcitabine plus or less Platinoids
• Previous gemcitabine delivered as a radiosensitizer for locally advanced disease, followed or not by a gemcitabine plus or less platinoids as maintenance or disease progression is allowed.
• Male or female less than 75 years of age
• Diagnosis of histologically or cytologically confirmed adenocarcinoma of the pancreas
• Locally advanced (non-resectable) or metastatic pancreatic cancer
• Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area
• ECOG performance status 0 to 1 at study entry
• Life expectancy: more than 3 months
• Neutrophils more than 1.5 x 109L, platelets more than 100 x 109L, and hemoglobin more than 10 gdL
• Bilirubin level either normal or less than 1.5 x ULN
• ASAT and ALAT normal or less than 2.5 x ULN (normal or less than 5 x ULN if liver metastasis are present)
• Serum creatinine less than 1.5 x ULN
• Amylase normal or less than 1.5 ULN
• Effective contraception for both male and female patients if the risk of conception exists
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial

Exclusion Criteria

• Brain metastases
• Previous treatment with irinotecan or fluoropyrimidines
• Significant cardiovascular disease: clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months
• Significant gastrointestinal abnormalities
• Gilbert's Syndrome
• Any uncontrolled infections
• Known HIV infection
• Radiotherapy within 4 weeks prior to study entry
• Any investigational agents 4 weeks prior to entry
• Known grade 3 or 4 allergic reaction to any of the components of the treatment
• Known drug abuse or alcohol abuse
• Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
• Women who are pregnant or breastfeeding
• Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix.
• Legal incapacity or limited legal capacity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alberto Zaniboni, MD

Role: STUDY_CHAIR

Fondazione GISCAD

Roberto Labianca, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione GISCAD

Locations

Ospedali Riuniti Umberto I - GM Lancisi-G Salesi

Ancona, Ancona, Italy

Ospedali Riuniti, Largo Barozzi, 1

Bergamo, Bergamo, Italy

A.O. Treviglio-Caravaggio, P.le Ospedale n1

Treviglio, Bergamo, Italy

Fondazione Poliambulanza, Via Bissolati 57

Brescia, Brescia, Italy

Azienda Ospedaliera "Di Liegro"

Gaeta, Latina, Italy

A.O. Carlo Poma - Via Albertoni, 1

Mantova, Mantova, Italy

A.O. Ospedale S.Paolo

Milan, MI, Italy

A.O. S.Salvatore

Pesaro, PS, Italy

Ospedale Morelli

Sondalo, SO, Italy

Countries

Italy

References

Zaniboni A, Aitini E, Barni S, Ferrari D, Cascinu S, Catalano V, Valmadre G, Ferrara D, Veltri E, Codignola C, Labianca R. FOLFIRI as second-line chemotherapy for advanced pancreatic cancer: a GISCAD multicenter phase II study. Cancer Chemother Pharmacol. 2012 Jun;69(6):1641-5. doi: 10.1007/s00280-012-1875-1. Epub 2012 May 11.

Reference Type: DERIVED

PMID: 22576338 (View on PubMed)

Other Identifiers

2008-004637-16

Identifier Type: -

Identifier Source: org_study_id