A Phase II Study of Triapine in Combination With Gemcitabine in Recurrent/Unresectable/Metastatic Pancreatic Carcinoma
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Phase II Study of Triapine in Combination With Gemcitabine in Recurrent/Unresectable/Metastatic Pancreatic Carcinoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response (complete and partial)
Safety Issue:
No
Principal Investigator
Malcolm J. Moore, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
United States: Federal Government
Study ID:
CDR0000353205
NCT ID:
NCT00078975
Start Date:
April 2004
Completion Date:
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- recurrent pancreatic cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- stage IV pancreatic cancer
- Pancreatic Neoplasms
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