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A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Metastatic Carcinoma of the Pancreas

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Metastatic Carcinoma of the Pancreas

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert L. DeJager, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Sankyo Inc.


United States: Federal Government

Study ID:




Start Date:

June 1999

Completion Date:

April 2005

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • duct cell adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811