Second Line Chemotherapy for Advanced Pancreatic Cancer

NCT01543412 | Completed Phase 2

• 1 other identifier: 2008-004637-16
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 9

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

Keywords

FOLFIRI; Metastases; pancreatic adenocarcinoma; locally advanced or metastatic pancreatic adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (RECIST Criteria)

  time from randomization date to date of death from any cause

  2 years

Secondary Outcomes (3)

• Safety and tolerability; Safety (CTC criteria - version 3.0)

  18 months

• Overall survival (OS)

  time from first cycle to death

• Progression Free Survival

  time from first cycle to progression or death

Study Arms (1)

FOLFIRI

EXPERIMENTAL

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.

Drug: FOLFIRI

Interventions

FOLFIRI 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

FOLFIRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente: lead
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (9)

Ospedali Riuniti Umberto I - GM Lancisi-G Salesi

Ancona, Ancona, 60126, Italy

Location

Ospedali Riuniti, Largo Barozzi, 1

Bergamo, Bergamo, 24128, Italy

Location

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

Treviglio, Bergamo, 24047, Italy

Location

Fondazione Poliambulanza, Via Bissolati 57

Brescia, Brescia, 25100, Italy

Location

Azienda Ospedaliera "Di Liegro"

Gaeta, Latina, 04024, Italy

Location

A.O. Carlo Poma - Via Albertoni, 1

Mantova, Mantova, 46100, Italy

Location

A.O. Ospedale S.Paolo

Milan, MI, 20100, Italy

Location

A.O. S.Salvatore

Pesaro, PS, 61100, Italy

Location

Ospedale Morelli

Sondalo, SO, 23100, Italy

Location

Related Publications (1)

• 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.

  PMID: 22576338 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

IFL protocol

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alberto Zaniboni, MD

  Fondazione GISCAD

  STUDY CHAIR

• Roberto Labianca, MD

  Fondazione GISCAD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: March 5, 2012
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 5, 2012

Record last verified: 2012-02

Locations

IT (9)