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
  Purpose

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.


Condition Intervention Phase
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
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 116
Study Start Date: July 2004
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: triapine
Given IV

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085371

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Investigators
Principal Investigator: Kyle Holen Mayo Clinic
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00085371     History of Changes
Other Study ID Numbers: NCI-2012-01452, NCI-2012-01452, MAYO-MC0345, CDR0000368762, NCI-6293, MC0345, 6293, N01CM62205
Study First Received: June 10, 2004
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma, Acinar Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014