Clinical trial NCT00078975: 3-AP and Gemcitabine in Treating Patients With Recurrent, Unresectable, or Metastatic Pancreatic Cancer
Official title: A Phase II Study of Triapine in Combination With Gemcitabine in Recurrent/Unresectable/Metastatic Pancreatic Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-03-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill more tumor cells by making them more sensitive to the drug.

PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with recurrent, unresectable, or metastatic pancreatic cancer.

Detailed description: OBJECTIVES:

Primary

* Determine the antitumor activity of 3-AP (Triapine®) and gemcitabine, in terms of complete and partial response and 6-month progression-free disease, in patients with recurrent, unresectable, or metastatic pancreatic cancer.

Secondary

* Determine the objective response rates, median survival, 1-year survival rate, duration of response or stable disease, and progression-free survival of patients treated with this regimen.
* Determine the safety and tolerability of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive 3-AP (Triapine®) IV over 2 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response receive an additional 2 courses of therapy beyond response.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 28-50 patients will be accrued for this study within 7-13 months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed pancreatic adenocarcinoma

  * Recurrent, unresectable, or metastatic disease
* At least 1 unidimensionally measurable lesion

  * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  * Prior radiation field must not have encompassed the only site of measurable disease
* No known brain metastases

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2 OR
* Karnofsky 60-100%

Life expectancy

* More than 12 weeks

Hematopoietic

* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* No G6PD deficiency

Hepatic

* Bilirubin ≤ 1.5 times normal
* AST and ALT ≤ 2.5 times upper limit of normal

Renal

* Creatinine ≤ 1.5 times normal OR
* Creatinine clearance ≥ 60 mL/min

Cardiovascular

* No unstable angina pectoris
* No cardiac arrhythmia
* No symptomatic congestive heart failure

Pulmonary

* No severe pulmonary disease
* No dyspnea at rest
* No dependence on supplemental oxygen use

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study treatment
* No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other concurrent uncontrolled illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy except fluorouracil given as adjuvant therapy OR as a radiosensitizer during radiotherapy
* More than 4 weeks since prior adjuvant fluorouracil therapy

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* See Chemotherapy
* More than 4 weeks since prior radiotherapy and recovered

Surgery

* Not specified

Other

* No other concurrent investigational agents
* No other concurrent anticancer therapy
* No concurrent combination antiretroviral therapy for HIV-positive patients

Primary outcomes:
measure: Objective response (complete and partial)
timeFrame: Every 8 weeks for the duration of the trial, an expected average of 5 years
measure: Prolonged stable disease rate
timeFrame: Stable disease of 6 or more months
Secondary outcomes:
measure: Median survival
timeFrame: For duration of trial, an expected average of 5 years
measure: Survival rate at 1 year
timeFrame: 1 year
measure: Response duration
timeFrame: From date of response until progression
measure: Progression-free survival
timeFrame: From date of response until progression or death
measure: Safety and tolerability
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Margaret and Charles Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program at London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Regional Cancer Centre - General Campus
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Malcolm J. Moore, MD
role: PRINCIPAL_INVESTIGATOR
References: