Clinical trial NCT00085371: Triapine as First-Line or Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
Official title: A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-06-11
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Survival in patients receiving triapine as first-line therapy
timeFrame: 6 months
measure: Survival in patients receiving triapine as second-line therapy
timeFrame: 4 months
Secondary outcomes:
measure: Incidence of adverse events assessed using CTCAE version 3.0
timeFrame: Up to 3 years
measure: Time to treatment failure
timeFrame: 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
measure: Overall survival
timeFrame: Up to 3 years
measure: Time to disease progression
timeFrame: Time from registration to documentation of disease progression, assessed up to 3 years
measure: Confirmed tumor response, defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
timeFrame: 6 months (first 6 courses of treatment)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kyle Holen
role: PRINCIPAL_INVESTIGATOR
References: