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Status:

COMPLETED

3-AP and Gemcitabine in Treating Patients With Recurrent, Unresectable, or Metastatic Pancreatic Cancer

Lead Sponsor:

University Health Network, Toronto

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill more tumor cel...

Detailed Description

OBJECTIVES: Primary * Determine the antitumor activity of 3-AP (Triapine®) and gemcitabine, in terms of complete and partial response and 6-month progression-free disease, in patients with recurrent...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed pancreatic adenocarcinoma
  • Recurrent, unresectable, or metastatic disease
  • At least 1 unidimensionally measurable lesion
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Prior radiation field must not have encompassed the only site of measurable disease
  • No known brain metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2 OR
  • Karnofsky 60-100%
  • Life expectancy
  • More than 12 weeks
  • Hematopoietic
  • WBC ≥ 3,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • No G6PD deficiency
  • Hepatic
  • Bilirubin ≤ 1.5 times normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Renal
  • Creatinine ≤ 1.5 times normal OR
  • Creatinine clearance ≥ 60 mL/min
  • Cardiovascular
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No symptomatic congestive heart failure
  • Pulmonary
  • No severe pulmonary disease
  • No dyspnea at rest
  • No dependence on supplemental oxygen use
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study treatment
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other concurrent uncontrolled illness that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • No prior chemotherapy except fluorouracil given as adjuvant therapy OR as a radiosensitizer during radiotherapy
  • More than 4 weeks since prior adjuvant fluorouracil therapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • See Disease Characteristics
  • See Chemotherapy
  • More than 4 weeks since prior radiotherapy and recovered
  • Surgery
  • Not specified
  • Other
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Exclusion

    Key Trial Info

    Start Date :

    April 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 7 2009

    Estimated Enrollment :

    26 Patients enrolled

    Trial Details

    Trial ID

    NCT00078975

    Start Date

    April 1 2004

    End Date

    January 7 2009

    Last Update

    September 14 2018

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, Canada, L8V 5C2

    2

    London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, Canada, N6A 4L6

    3

    Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, Canada, K1H 1C4

    4

    Princess Margaret Hospital

    Toronto, Ontario, Canada, M5G 2M9