Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Pancreatic Cancer
OBJECTIVES: I. Determine the activity of glufosfamide as determined by objective response in
patients with metastatic or inoperable locally advanced pancreatic cancer. II. Determine the
response rate in this patient population after this treatment. III. Determine the duration
of objective response in these patients on this treatment. IV. Determine the toxic effects
of this regimen in these patients. V. Assess the impact of hydration on the toxicity profile
of this treatment in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms: Arm I: Patients receive glufosfamide IV over 1 hour on day 1. Arm II:
Patients receive glufosfamide as in arm I. Patients are hydrated with excess physiological
saline solution 4 hours before and for 3 hours after treatment with glufosfamide. Treatment
repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients with an objective complete response continue treatment for a maximum of 2 courses
beyond confirmation of response. Patients are followed every 6 weeks until disease
progression.
PROJECTED ACCRUAL: A total of 16-32 patients (8-16 per arm) will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven metastatic or inoperable locally advanced
pancreatic adenocarcinoma At least 1 target lesion accurately measurable in at least 1
dimension Longest diameter at least 20 mm with conventional techniques or at least 10 mm
with spiral CT scan No symptomatic brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN)
Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5
times ULN for liver metastases) Renal: Creatinine no greater than 1.7 mg/dL Creatinine
clearance at least 60 mL/min Cardiovascular: Normal cardiac function No history of
ischemic heart disease No history of congestive heart failure within the past 6 months
Normal 12 lead electrocardiogram Other: Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception No other prior or concurrent malignancy,
except: Cone biopsied carcinoma of the cervix Adequately treated basal or squamous cell
skin cancer No unstable systemic disease No active uncontrolled infection No
psychological, familial, sociological, or geographical condition that would preclude study
compliance
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic filgrastim (G-CSF)
No concurrent prophylactic growth factors Chemotherapy: No prior chemotherapy for
metastatic or advanced disease Endocrine therapy: Not specified Radiotherapy: At least 4
weeks since prior radiotherapy Concurrent radiotherapy allowed provided not all target
lesions are in irradiated field Surgery: At least 2 weeks since prior major surgery Other:
No other concurrent anticancer agents No other concurrent investigational therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Nicholas A. Pavlidis, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Ioannina
Authority:
United States: Federal Government
Study ID:
EORTC-16994P
NCT ID:
NCT00005053
Start Date:
December 1999
Completion Date:
Related Keywords:
- Pancreatic Cancer
- stage III pancreatic cancer
- recurrent pancreatic cancer
- adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Pancreatic Neoplasms
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