Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

DX-8951f in Treating Patients With Metastatic Cancer of the Pancreas

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Pharmaceutical / Industry	DAIICHI-8951A-PRT009 JHOC-99062405, MSKCC-99014, NCT00003951

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. 

Entry 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

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

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

Expected Enrollment

A total of 12-37 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Daiichi Sankyo, Incorporated

Robert L. DeJager, MD, FACP, Protocol chair		Ph: 201-573-7160 Email: RDeJager@DaiichiUS.com

Registry Information
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
Trial Start Date		1999-06-18
Registered in ClinicalTrials.gov		NCT00003951
Date Submitted to PDQ		1999-06-23
Information Last Verified		2007-04-23

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