Second Line Chemotherapy for Advanced Pancreatic Cancer

NCT01543412

Last updated date
Study Location
A.O. Treviglio-Caravaggio, P.le Ospedale n1
Treviglio, Bergamo, 24047, Italy
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pancreatic Adenocarcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Second Line Chemotherapy for Advanced Pancreatic Cancer
Official Title  ICMJE Folfiri as Second-Line Chemotherapy for Advanced Pancreatic Cancer. A GISCAD Phase II Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Adenocarcinoma
Intervention  ICMJE Drug: 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
Study Arms  ICMJE Experimental: 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.
Intervention: Drug: FOLFIRI
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2012)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01543412
Other Study ID Numbers  ICMJE 2008-004637-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Study Sponsor  ICMJE Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Chair:Alberto Zaniboni, MDFondazione GISCAD
Principal Investigator:Roberto Labianca, MDFondazione GISCAD
PRS Account Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Verification Date February 2012

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