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Triapine as First-Line or Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00085371
First received: June 10, 2004
Last updated: October 7, 2013
Last verified: October 2013

June 10, 2004
October 7, 2013
July 2004
July 2006   (final data collection date for primary outcome measure)
  • Survival in patients receiving triapine as first-line therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The point estimate of the success rates will be calculated as the number of successes divided by the number of evaluable patients, with confidence intervals calculated by the method of Duffy and Santner.
  • Survival in patients receiving triapine as second-line therapy [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The point estimate of the success rates will be calculated as the number of successes divided by the number of evaluable patients, with confidence intervals calculated by the method of Duffy and Santner.
Not Provided
Complete list of historical versions of study NCT00085371 on ClinicalTrials.gov Archive Site
  • Incidence of adverse events assessed using CTCAE version 3.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • Time to treatment failure [ Time Frame: Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Time to disease progression [ Time Frame: Time from registration to documentation of disease progression, assessed up to 3 years ] [ Designated as safety issue: No ]
    The distribution of time to progression will be estimated using the method of Kaplan-Meier.
  • Confirmed tumor response, defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart [ Time Frame: 6 months (first 6 courses of treatment) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Triapine as First-Line or Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas

This phase II trial is studying how well triapine works as first-line or second-line therapy in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the pancreas. Drugs used in chemotherapy, such as triapine, work in different ways to stop tumor cells from dividing so they stop growing or die.

PRIMARY OBJECTIVES:

I. Determine the 3- and 6-month survival rate of patients with locally advanced or metastatic adenocarcinoma of the pancreas treated with 3-AP (Triapine^®) as first- or second-line therapy.

SECONDARY OBJECTIVES:

I. Determine the toxicity and tolerability of this drug in these patients. II. Determine the time to treatment failure in patients treated with this drug. III. Determine overall survival and disease progression in patients treated with this drug.

IV. Determine tumor response in patients treated with this drug. V. Determine laboratory studies that will increase our understanding of Triapine and its effects on cellular processes.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no).

Patients receive triapene IV over 2 hours on days 1-4 and 15-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3-6 months for 3 years.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acinar Cell Adenocarcinoma of the Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
Drug: triapine
Given IV
Experimental: Treatment (triapene)
Patients receive triapene IV over 2 hours on days 1-4 and 15-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: triapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
Not Provided
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas

    • Unresectable disease
    • Locally advanced or metastatic disease
  • At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan

    • Measurable lesions outside prior radiotherapy field OR measurable lesions actively growing in the site of prior radiotherapy
  • No prior chemotherapy OR previously treated with 1, and only 1, gemcitabine-containing regimen for metastatic, unresectable, or locally advanced pancreatic cancer

    • Adjuvant therapy not considered prior chemotherapy if all treatment was completed > 6 months before tumor recurrence
  • No known brain metastases
  • Performance status - ECOG 0-2
  • At least 6 weeks
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 75,000/mm^3
  • AST =< 3 times upper limit of normal (ULN)
  • Bilirubin =< 1.5 times ULN
  • Creatinine =< 1.5 times ULN
  • Creatinine clearance > 60 mL/min
  • No uncontrolled congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No pulmonary disease requiring oxygen
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No glucose-6-phosphate dehydrogenase (G6PD) deficiency (for patients of African, Asian, or Mediterranean origin or ancestry)
  • No active or ongoing infection
  • No hypersensitivity or severe allergic reaction to 3-AP (Triapine®) or related compounds
  • No concurrent uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance
  • No other concurrent antineoplastic therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational therapy for the malignancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00085371
NCI-2012-01452, NCI-2012-01452, MAYO-MC0345, CDR0000368762, NCI-6293, MC0345, 6293, N01CM62205
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Kyle Holen Mayo Clinic
National Cancer Institute (NCI)
October 2013

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