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

Stage IV Pancreatic Cancer Clinical Trial

Official title:

A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00085371
• Other study ID #: NCI-2012-01452
• Secondary ID: NCI-2012-01452MA
• Status: Completed
• Phase: Phase 2
• First received: June 10, 2004
• Last updated: October 7, 2013
• Start date: July 2004

Study information

• Verified date: October 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acinar Cell Adenocarcinoma of the Pancreas
• Adenocarcinoma
• Duct Cell Adenocarcinoma of the Pancreas
• Pancreatic Neoplasms
• Recurrent Pancreatic Cancer
• Stage III Pancreatic Cancer
• Stage IV Pancreatic Cancer

Intervention

Drug:
• triapine
Given IV

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival in patients receiving triapine as first-line therapy	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.	6 months	No
Primary	Survival in patients receiving triapine as second-line therapy	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.	4 months	No
Secondary	Incidence of adverse events assessed using CTCAE version 3.0		Up to 3 years	Yes
Secondary	Time to treatment failure		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	No
Secondary	Overall survival		Up to 3 years	No
Secondary	Time to disease progression	The distribution of time to progression will be estimated using the method of Kaplan-Meier.	Time from registration to documentation of disease progression, assessed up to 3 years	No
Secondary	Confirmed tumor response, defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart		6 months (first 6 courses of treatment)	No