DX-8951f in Treating Patients With Metastatic Cancer of the Pancreas
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Cancer
Intervention: exatecan mesylate (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Daiichi Sankyo Inc. Official(s) and/or principal investigator(s):
Robert L. DeJager, MD, FACP, Study Chair, Affiliation: Daiichi Sankyo Inc.
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have
metastatic cancer of the pancreas that has not been previously treated or that has not
responded to previous chemotherapy.
Clinical Details
Official title: A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Metastatic Carcinoma of the Pancreas
Study design: Treatment
Detailed description:
OBJECTIVES: I. Determine the objective response rate in patients with metastatic carcinoma of
the exocrine pancreas treated with DX-8951f. II. Determine the time to tumor progression in
patients receiving this drug. III. Determine the survival at 6 and 12 months of patients
receiving this drug. IV. Evaluate the quantitative and qualitative toxicities of this regimen
in this patient population. V. Evaluate the pharmacokinetics of this drug in this patient
population.
OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every
21 days. Treatment continues in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed epithelial cancer of the
exocrine pancreas Metastatic disease Previously untreated disease or progressive disease
after first-line chemotherapy Bidimensionally measurable disease Indicator lesion must be
outside of any prior radiation port No brain metastases No islet cell tumors, lymphoma, or
sarcoma of the pancreas
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1. 5 mg/dL SGOT/SGPT no greater than
2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal:
Creatinine no greater than 1. 5 mg/dL Cardiovascular: No active congestive heart failure No
uncontrolled angina No myocardial infarction within the past 6 months Other: Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception No
concurrent serious infection No history of other malignancy within the past 5 years except
nonmelanoma skin cancer or carcinoma in situ of the cervix No overt psychosis, mental
disability, or incompetence No other life threatening illness
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy No prophylactic
colony stimulating factors to prevent neutropenia Chemotherapy: See Disease Characteristics
At least 4 weeks since prior chemotherapy and recovered No other concurrent cytotoxic
chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At
least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At
least 4 weeks since prior major surgery and recovered No concurrent surgery Other: No other
concurrent anticancer treatment At least 28 days since other prior investigational drugs,
including analgesics or antiemetics No other investigational drugs during and for 28 days
after study No concurrent drugs that induce or inhibit CYP3A enzyme
Locations and Contacts
Johns Hopkins Oncology Center, Baltimore, Maryland 21287, United States
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 1999
Last updated: May 23, 2008
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