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

NCT00085371 | Completed Phase 2

• 7 other identifiers: NCI-2012-01452MAYO-MC0345CDR0000368762NCI-6293MC03456293N01CM62205
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• Incidence of adverse events assessed using CTCAE version 3.0

  Up to 3 years

• 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

• Overall survival

  Up to 3 years

• Time to disease progression

  Time from registration to documentation of disease progression, assessed up to 3 years

• 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)

Study Arms (1)

Treatment (triapene)

EXPERIMENTAL

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

Interventions

triapine DRUG

Given IV

Treatment (triapene)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

3-aminopyridine-2-carboxaldehyde thiosemicarbazone

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Kyle Holen

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: July 1, 2004
• Primary Completion: July 1, 2006
• Last Updated: October 8, 2013

Record last verified: 2013-10

Locations

US (1)