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A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer, Biliary Cancer

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Trial Information

A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers


Gemcitabine combined with 5FU may enhance the activity of 5-FU in vivo. Gemcitabine is an
inhibitor of ribonucleotide reductase, an enzyme needed for synthesis of deoxynucleotides,
and 5-FU interferes with dTTP synthesis by inhibition of thymidylate synthase (TS). It is
likely that concomitant administration of gemcitabine and 5FU results in increased
cytotoxicity by reducing intracellular dTTP thru two different mechanisms, thereby
inhibiting DNA replication and repair. Platinum compounds lead to cell death by forming DNA
adducts and causing double strand breaks. By inhibiting DNA synthesis and repair, both
gemcitabine and 5-FU potentiate the activity of cisplatin. These interactions underlie the
clinical synergisim that has been observed with platinum/5FU and platinum/gemcitabine
combinations(Colucci et al., 2002, Louvet et al., 2005, Berlin et al., 2002, Cunningham et
al., 2009, Heinemann et al., 2008, Valle et al., 2010).


Inclusion Criteria:



- Patients must have histologic or cytologic diagnosis of pancreatic adenocarcinoma or
biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma or gallbladder
carcinoma).

- Patients must have clinical/radiologic evidence of metastatic disease.

- Previous systemic therapy for metastatic disease limited to one cytotoxic
chemotherapy regimen not containing cisplatin. Previous therapy for metastatic
disease might have included gemcitabine or infusional 5-FU but not both agents.

- ECOG performance status < 1

- Patients must have adequate bone marrow (absolute neutrophil count >1,500/mm3,
platelet count >100,000/mm3) and renal function (serum creatinine < 1.25 x ULN).

- Patients must have at least one measurable lesion per RECIST criteria.

- Patients must be free of serious concomitant medical disorders incompatible with
study participation including active infection requiring systemic therapy.

- Previous malignancies are permitted provided that they have been treated with
curative intent and patient is without evidence of active systemic disease.

- Patients must be informed of the investigational nature of this study and provide
written informed consent prior to receiving protocol treatment.

Exclusion Criteria:

- Patients with pre-existing peripheral neuropathy > grade 2 are ineligible.

- Previous systemic therapy for metastatic disease limited to one cytotoxic
chemotherapy regimen not containing cisplatin.

- Previous therapy for metastatic disease might have included gemcitabine or infusional
5-FU but not both agents.

- Serious concomitant medical disorders incompatible with study participation including
active infection requiring systemic therapy.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

The primary objective of this clinical trial is to estimate the best objective response rate to treatment with the triplet chemotherapy regimen of gemcitabine, infusional 5-FU, and cisplatin, in untreated and previously treated advanced pancreatic and biliary cancer patients.

Outcome Time Frame:

28 days

Safety Issue:

No

Principal Investigator

Mark Zalupski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

UMCC 2011.036

NCT ID:

NCT01661114

Start Date:

July 2011

Completion Date:

July 2016

Related Keywords:

  • Pancreatic Cancer
  • Biliary Cancer
  • Gemcitabine, Infusional 5-Fluorouracil,Cisplatin
  • Advanced Pancreatic and Biliary Cancers
  • untreated & previously treated pancreatic & biliary cancer.
  • Pancreatic Neoplasms
  • Biliary Tract Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752