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

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Brief Title

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

Official Title

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

Brief Summary

      Multi-agent chemotherapy has value for patients with advanced pancreatic-biliary cancers
      leading to responses in a substantial minority and increasing survival. The use of the
      FOLFIRINOX regimen is limited by its' intensity and toxicity. Previous protocol and clinical
      experience within the University of Michigan Pancreatic Program leads to an expectation of
      tolerance and efficacy of the proposed regimen. Advantages of the proposed regimen relative
      to FOLFIRINOX include:

        1. Substitution of gemcitabine for irinotecan. Single agent activity of gemcitabine is at
           least as good as irinotecan (probably better, especially when delivered by FDR
           [fixed-dose rate] infusion) and gemcitabine is much better tolerated with less diarrhea,
           nausea/emesis, myelosuppression and alopecia.

        2. Deletion of leucovorin infusion and 5FU bolus injection will lessen myelosuppression,
           mucositis and diarrhea.

        3. Substitution of cisplatin for oxaliplatin will reduce cost of therapy and avoid cold
           aggravated dysesthesia.

      Presuming evidence of efficacy and confirmation of tolerance with the proposed regimen, the
      investigators believe this treatment may be more widely applicable to pancreatic-biliary
      cancer patients, including those with advanced disease as well as being considered for use in
      locally advanced and neo- and adjuvant settings.
    

Detailed Description

      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 synergism
      that has been observed with platinum/5FU and platinum/gemcitabine combinations.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment

Secondary Outcome

 Median Overall Survival of Previously Treated and Previously Untreated Patients

Condition

Pancreatic Cancer

Intervention

Gemcitabine

Study Arms / Comparison Groups

 Gemcitabine, 5-FU and Cisplatin
Description:  4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

39

Start Date

July 2011

Completion Date

March 2016

Primary Completion Date

December 2014

Eligibility Criteria

        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 (Eastern Cooperative Oncology Group) performance status < 1 (A measure of quality
             of life where 0 represents asymptomatic and 5 represents death).

          -  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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mark Zalupski, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01661114

Organization ID

UMCC 2011.036

Secondary IDs

HUM 49518

Responsible Party

Sponsor

Study Sponsor

University of Michigan Rogel Cancer Center


Study Sponsor

Mark Zalupski, MD, Principal Investigator, University of Michigan Rogel Cancer Center


Verification Date

September 2016